Fmc Forestdale

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49894 Based on review of the Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, facility Absence and Hospitalization, Discharged to Hospital documentation, medical record (MR), facility grievance log, facility policies and procedure, Combiset Hemodialysis Blood Tubing Set Manufacturer’s Directions for Use (DFU), facility Adverse (Safety) Events/ Report documentation, and staff interviews, it was determined the facility failed to: 1. Follow State Licensure Rules for End Stage Renal Disease for reporting all unusual occurrences to the State Survey Agency (SSA) for unscheduled transports to a hospital and a safety event involving a firearm in the facility. 2. Follow facility policy and bloodline manufacturer’s DFU by maintaining the arterial drip chamber (a pressure and a monitoring component of the dialysis bloodline tubing) fluid levels to the required fill level. 3. Follow facility policy for repairs for treatment chairs on the dialysis treatment floor. 4. Follow facility policy for repairs to the automatic handicap access door leading onto the treatment floor. 5. Ensure patient rights were respected and protected and staff treated all patients with respect. 6. Complete an unstable assessment and plan of care for a patient at risk for an Involuntary Discharge (IVD) per facility policies. 7. Ensure staff performed vital signs, machine parameters, and safety checks, at least every thirty minutes or more as needed, not to exceed forty-five minutes per facility policy. 8. Ensure a Patient Care Technician (PCT) reported abnormal findings to the Registered Nurse (RN) per facility policy. 9. Ensure staff notified the physician of post weights above or below Estimated Dry Weight (EDW) per facility policy. 10. Ensure staff followed the physician’s order for Blood Flow Rate (BFR). 11. Ensure staff followed the physician’s order for Dialysate Flow Rate (DFR). 12. Ensure staff reported treatment prescription variances to the physician. 13. Ensure all reportable safety events identified were documented in the facility Safety Event Report system. 14. Ensure staff followed the facility policy for weapons and firearms. 15. Ensure staff maintained professional behavior on the hemodialysis treatment floor. 16. Document patient grievances and follow facility policy for the grievance submission, acknowledgement, investigation, review, response, and communication of patient grievances. This affected an unsampled patient, twelve unsampled patients, Patient Identifier (PI) # 1, PI # 2, PI # 3, PI # 4, PI # 5, and had the potential to affect all 51 patients served by the facility. Refer to V 101, V 403, V 452, V 520, V 540, V 543, V 544, V 634, V 715, V 751, and V 765 for findings.”

“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: 30952 Based on review of the Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, the facility Absence and Hospitalization, Discharged to Hospital documentation, medical record (MR), and staff interviews, it was determined the facility failed to follow State Licensure Rules for End Stage Renal Disease for reporting all unusual occurrences to the State Survey Agency (SSA) for unscheduled transports to a hospital and a safety event involving a firearm in the facility. This affected unsampled patient # 6, Patient Identifier (PI) # 3, PI # 5, and had the potential to affect all 51 patients served by the facility. Findings include: Rules of Alabama State Board of Health Alabama Department of Public Health (ADPH) Chapter 420-5-5 End Stage Renal Disease Treatment (ESRD) and Transplant Centers Amended December 18, 2007 page 7 420-5-5-.01 General (7) Unusual Occurrences Unusual occurrences (UO) which threaten the welfare, safety and health of patients, personnel or visitors shall be reported by the ESRD facility within 24 hours, either by telephone (and confirmed in writing), or by facsimile to the ADPH... as required. Examples of unusual occurrences include: ... Any acute event that results in a patient receiving emergency treatment must be reported. Emergency treatment includes unscheduled transportation to a hospital or receipt of cardiac life support from a hospital, ambulance service or rescue squad, or staff member... 1. Review of the facility Absence and Hospitalization, Discharged to Hospital documentation dated 12/6/24 to 5/6/25 revealed unsampled patient # 6 was discharged to the hospital from the dialysis facility on 12/16/24. Review of SSA UO online reports submitted by the facility from 7/1/24 to 5/2/25 revealed no documentation the 12/16/24 discharge to the hospital was reported to the SSA online system. An interview was conducted on 5/7/25 at 3:03 PM with Employee Identifier (EI) # 3, Clinical Nurse Manager, who confirmed no UO report was submitted to the SSA for the 12/16/24 discharge to the hospital. ` 2. PI # 3 was admitted to the facility on 11/16/23 with diagnoses including ESRD. Review of the Plan of Care (POC) dated 12/19/24 revealed Social Worker (SW) Assessment documentation that PI # 3 was rushed to the emergency room (ER) during rounds. Review of the facility Absence and Hospitalization documentation revealed PI # 3 was hospitalized 12/19/24 to 12/31/24. Review of SSA UO online reports submitted by the facility from 7/1/24 to 5/2/25 revealed no documentation the 12/19/24 ER transfer was reported to the SSA online system. An interview was conducted on 5/8/25 at 11:44 AM with EI # 3, who confirmed there was no documentation staff reported to the SSA the unscheduled transfer from the facility to a hospital. 3. PI # 5 was admitted to the facility on 10/14/24 with a diagnosis of ESRD. Review of a Clinical Notes Report dated 2/5/25 at 9:14 AM, which revealed PI # 5 brought a firearm into the facility in violation of the No Weapons Policy, the Interdisciplinary Team members would speak with PI # 5 prior to the 2/5/25 dialysis treatment, cooperation advised to avoid discharge from the facility, and no bags would be allowed in the facility. Review of documentation provided to the surveyor, A Letter of Concern, dated 2/4/25, and a Governing Body Meeting, dated 2/6/25, revealed PI # 5 brought a concealed handgun into the facility, weapons are prohibited on the property, and violation of the policy may result in immediate discharge from the facility. Review of the SSA UO reports submitted by the facility from 7/1/24 to 5/2/25 failed to include the discovery of a firearm on PI # 5 during treatment, which had the potential to cause serious harm to patients, staff, and visitors. An interview was conducted on 5/8/25 at 2:45 PM with EI # 2, Director of Operations, and EI # 3, who confirmed staff failed to report the discovery of a firearm in the facility, an UO, to the SSA online reporting system.”

“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: 49894 Based on observations, review of facility policies, Combiset Hemodialysis Blood Tubing Set Manufacturer’s Directions for Use (DFU), and patient and staff interviews, it was determined the facility failed to ensure: 1. Staff followed the facility policy and bloodline manufacturer’s DFU by maintaining the arterial drip chamber (a pressure and a monitoring component of the dialysis bloodline tubing) fluid levels to the required fill level. 2. Staff followed the facility policy for repairs for treatment chairs on the dialysis treatment floor. 3. Staff followed facility policy for repairs to the automatic handicap access door leading onto the treatment floor. These deficient practices had the potential to affect all 51 patients dialyzing at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Date Published: 5/1/23 ...During Treatment Follow the steps for monitoring patient and machine parameters during treatment: ...Step 3 Machine Parameters and Extracorporeal Circuit ...Venous and arterial chambers (ADC) are filled to the fill level. Manufacturer’s Directions for Use Combiset True Flow Series Hemodialysis Blood Tubing Set ...Dialysis Treatment Precautions ...2. During Treatment ...b. Maintain fluid level in pre-pump arterial chamber at 85 to 95 percent (%) full...readjust levels as needed. Facility Policy: Equipment Installation-Operation-Maintenance-Repair-And Disposal Date Published: 7/6/21 ...Repairs Any equipment or device that is not fully functioning in accordance with Instructions for use or company policy, must be repaired or replaced... 1. Observations of care and patient interviews were conducted on the treatment floor on 5/6/25 and 5/7/25. On 5/6/25, eight ADCs were observed to be below the fill line from 9:25 AM to 1:10 PM. On 5/7/25, seven ADCs were observed to be below the fill line from 8:40 AM to 12:50 PM. On 5/7/25 between 8:50 AM and 9:54 AM, the surveyor observed the ADCs at station 1, station 2, station 3, and station 4 less than 30 % full. An interview was conducted on 5/7/25 at 9:55 AM with Employee Identifier (EI) # 9, Certified Clinical Hemodialysis Technician, who confirmed the finding and filled the ADC to an acceptable level. An interview was conducted on 5/8/25 at 3:03 PM with EI # 3, Clinical Nurse Manager, who confirmed staff failed to maintain the ADCs at 85 to 95 % per the facility policy and manufacturer’s DFU. 2. An interview was conducted on 5/6/25 at 9:25 AM with an unsampled patient # 2. The patient reported he/she had verbally complained to the floor staff and nurse that the handicap accessible door leading to the treatment room was broken. The patient stated he/she uses an ambulatory assistive device; the door is very heavy, and the automatic door opener had been broken for several months. Documentation provided by EI # 2, Director of Operations, revealed a work order was placed on 3/10/25 for repair of the door. Further documentation revealed a quote on 4/7/25 for repair of the door and a quote on 4/30/25 for parts and labor for repairs to the door. The treatment door remained in disrepair upon surveyor entrance to the facility on 5/6/25. An interview was conducted on 5/8/25 at 8:25 AM with EI # 2, who stated there was an emergency request for repairs to the door placed on 5/7/25 and reported the treatment door would be repaired within seven days. 3. Patient interviews were conducted on the treatment floor on 5/6/25 and 5/7/25. Patients reported staff had been informed the treatment chairs were not comfortable for a four to four- and half-hour dialysis treatment. Unsampled patient # 4 and unsampled patient # 5 had complained of chairs not working properly, and staff was aware of this for some time. Surveyors witnessed the chairs of both patients who had complaints. Unsampled patient # 5 demonstrated his/her treatment chair would not easily recline and remain in the desired position. The foot rest of unsampled patient # 5 was propped up with a stool. An interview was conducted on 5/7/25 at 3:03 PM with EI # 3, who stated he/she was unaware of patient treatment chairs in need of repair. 30952”

“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: 49894 Based on observations, review of facility policy, facility grievance documentation, patient and staff interviews, it was determined the facility failed to ensure patient rights were respected and protected and staff treated all patients with respect. This deficient practice did affect Patient Identifier (PI) # 1 and had the potential to affect all 51 patients dialyzing at the facility. Findings include: Facility Policy: Patient Rights and Responsibilities Policy Number: Not Listed Version: 2 Date Published: 4/4/12 ...dialysis facilities...must protect and provide for the exercise of those rights. Patient rights as stated in the Conditions for Coverage: Condition for Coverage 494.70 Patients’ Rights 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 End Stage Renal Disease. Patient interviews conducted 5/6/25 and 5/7/25 revealed the following: An interview was conducted on 5/6/25 at 9:32 AM with PI # 1. PI # 1 states he/she has filed multiple grievances concerning staff member # 1, and asked that staff member # 1 not come near him/her or touch his/her machine. According to the patient, after the first grievance was filed, staff member # 1 continued to touch his/her machine, come into the area of the treatment floor where he/she was dialyzing, and stare intimidatingly at him/her from across the room. PI # 1 states the staff member stood on the scale with him/her and yelled in his/her ear “EXCUSE YOU!” An interview was conducted on 5/6/25 at 11:55 AM with an unsampled patient # 1, who confirmed PI # 1’s complaints, stated they had also filed a grievance concerning staff member # 1, and stated they witnessed staff member # 1 stand on the scale and yell at PI # 1, staff member # 1 come into PI # 1’s treatment area, and stare intimidatingly at PI #1. Unsampled patient # 1 also stated staff member # 1 stares intimidatingly at him/her during treatment since he/she filed a grievance concerning staff member # 1. An interview conducted on 5/7/25 at 3:03 PM with EI # 3, Clinical Nurse Manager, confirmed this has been an ongoing issue with this patient and staff member. EI # 3 stated the patient had met with EI # 1, Medical Director, and EI # 2, Director of Operations. EI # 3 reported the staff member does not provide care to PI # 1.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 30952 Based on record review, facility documentation, policies, and interviews, it was determined the facility failed to complete an unstable assessment and plan of care of one of one sampled patient, Patient Identifier (PI) # 5, at risk for an Involuntary Discharge (IVD) per facility policies. The failure to complete an unstable care plan created missed opportunities for improvement and could affect 51 in-center patients. Findings include: Policy Title: Weapons and Firearms Published: 4/5/21 Policy ...patients ...are prohibited from carrying ...concealed handguns .... Weapons re prohibited ...Within any Fresenius Kidney Care property ... Violation of this policy may result in ...involuntary discharge for patients ... Documentation of all actions taken should be made in ...medical record documentation ... Policy Title: Disruptive Patient Behavior and Use of Behavioral Agreement Published: 2/3/25 Purpose ...provide guidelines on managing ...disruptive patient behavior ...to ensure all patients receive safe treatment, and an appropriate environment exists for all who are present. Definitions Disruptive Behavior: Behavior that affect the safety and welfare of others. ...Background ...the patient has the right to respect, dignity, and recognition of ...needs, sensitivity to ...physiological needs and ability to cope ... Review Process for Disruptive Behavior All incidents involving disruptive or dangerous behavior must be immediately reported to the Clinical Manager (CM) or nurse in charge. ...The Interdisciplinary team (IDT) will determine the need for a comprehensive interdisciplinary assessment (CIA) to determine the root cause (RC) of the behavior, and what changes are needed to the plan of care (POC). ...Document the following in the medical record (MR): The incident ... All interventions to defuse or address the ...behavior. Outcome of these efforts. Enter a patient safety event per policy, if applicable. Documentation may be made in a clinical note, progress note ...update in the CIA and Plan of Care (POC) or as a new CIA and POC ... Use of Behavioral Agreements A Behavioral Agreement is a tool that should be considered for cases in which any of the following apply: ...The patient’s behavior has potential to harm the patient or others. The patient’s behavior will potentially result in termination of dialysis services if it is not ...stopped ... Behavioral Agreements Requirements ...Responsibilities of the IDT in working with the patient to achieve success such as weekly meetings ...counselors, monthly meeting with the team to review progress ... The SW (Social Worker) will consult SW Leadership ...to determine if a behavioral agreement is appropriate ... POC Any patient at risk for IVD must be considered “unstable” and reassess by the IDT. The POC should be revised or adjusted, as indicated, to demonstrate interventions, boundaries, or resources agreed upon ... Policy Title: Immediate and Non-Immediate Involuntary Patient Discharge-- Published: 11/4/24 ...Policy The Medical Director shall ensure... 4. The patient’s behavior...deemed dangerous to health and safety of others (Examples: A patient with a gun or knife or...). Required Documentation ...a patient who is at risk for IVD must be considered unstable and reassessed by the IDT...document...the reassessments, ongoing problems(s), and effort(s) made to resolve the problem(s). Facility Policy: Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) Published: 7/3/23 ...The CIA and POC must be developed be developed and implemented by an... IDT consisting of at a minimum, the patient... registered nurse.... attending physician... qualified master’s degree level SW and qualified registered dietician. ...Patient stability must be reviewed monthly. The IDT will offer input to the attending physician who will determine whether the patient is stable or unstable on the criteria included in this policy. ...CIA/POC for Unstable Patients Unstable patients must be reassessed by the IDT monthly. Monthly reassessment and any POC updates...must be documented until the issues have been resolved... The following are unstable criteria: ...Significant change in psychosocial needs a. Change in... psychosocial needs severe enough to interfere...with the treatment plan...Any patient considered at risk for IVD, or transfer must be considered “unstable” under this category... 1. PI # 5 was admitted to the facility on 10/15/24 with a diagnosis of End Stage Renal Disease. Review of a Clinical Notes Report dated 2/5/25 at 9:14 AM, revealed PI # 5 was in violation of the No Weapons Policy, IDT members would speak with PI # 5 prior to the 2/5/25 dialysis treatment, advised cooperation to avoid discharge from the facility, and no bags would be allowed in the facility. PI # 5 communicated remorse, and compliance with IDT directives. Further record review revealed no IDT conversation/meeting with PI # 5, as reported in the 2/5/25 Clinical Notes Report, and no IDT assessment/reassessments were documented. Review of documentation provided to the surveyor included, A Letter of Concern, dated 2/4/25, and a Governing Body Meeting, dated 2/6/25. Review of The Letter of Concern, revealed PI # 5’s demonstrated behavior, carrying concealed handguns on the property was prohibited, and violation may result in immediate discharge from the facility. The Letter was signed by PI # 5, and the Clinical Nurse Manager (CNM), Employee Identifier (EI) # 3. Review of the Meeting of the Governing Body on 2/6/25 at 3:30 PM, attended by EI # 1, the Medical Director (MD), EI # 2, Director of Operations (DO), EI # 3, and the Regional Vice President, identified the 1/31/25 firearm discovery, the 2/3/25 staff reporting of the incident to EI # 3, the 2/4/25 Letter of Concern completion, the 2/5/25 meeting with the CM and MD to present the Letter of Concern, ensure PI # 5’s safety, review the Weapons/Firearms Policy, Patient’s Rights and Responsibility, and inform security of new safety measures in place. Review of the Provider Note documentation dated 3/5/25 revealed PI # 5 remains noncompliant with treatment, has flat affect, poor eye contact, very poorly compliant with treatment and minimally engaged with providers. Review of the record revealed a 90 Day POC meeting dated 3/5/25 and IDT Annual Comprehensive Assessments completed by the Registered Nurse (RN), SW, and Registered Dietician (RD). There was no documentation of the firearm discovery, actions taken to ensure PI # 5 continued to dialyze at the facility, and PI # 5’s adherence/non-adherence. There was no psychosocial documentation related to PI # 5’s behavior, violation of the firearms policy, compliance /lack of compliance following the safety event, and the IDT consideration of an unstable POC with monthly updates. An interview was conducted on 5/6/25 at 2:14 PM with EI # 7, Clinic SW, who reported the facility firearm policy “...is basically, no firearms allowed in the clinic.” EI # 7 reported an IDT meeting was held with PI # 5 and separate from PI # 5. EI # 7 reported there was IDT discussion, “... we just took his/her word, there was no behavior contract or IVD. He/she probably should have been on a behavior contract, there is a history of depression in a sister facility SW note.” An interview was conducted on 5/8/25 at 10:00 AM with EI # 1, who reported psychosocial needs are routinely reviewed during care planning rounds. The surveyor asked EI # 1 if the IDT discussed whether a behavioral contract was appropriate for PI # 5. EI # 1 responsed, “I don’t know the formal answer, but no personal items can be brought into the clinic.” EI # 1 was asked if bringing firearms into the facility would put a patient at risk for IVD? EI # 1 response, “Yes.” EI # 1 was asked if the IDT considered whether PI # 5 should be made unstable. EI # 1 responded, “... the IDT did not discuss.” An interview was conducted on 5/8/25 at 10:26 AM with EI # 2, who reported after review of the facility disruptive behavior policy, we did not document what we should have. The surveyor asked if the presence of a firearm on the premises put the patient at risk for IVD? EI # 2 response, “Yes.” EI # 2 was asked if the possibility of an IVD make PI # 5 unstable? EI # 2 confirmed PI # 5 “...should have been made unstable for more frequent monitoring.” The IDT failed to follow its own policies for a patient at risk for IVD.”

“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: 49894 Based on review of medical records (MR), facility policies and procedure, and staff interviews, it was determined the facility failed to ensure: 1. Staff performed vital signs (VS), machine parameters, and safety checks, at least every thirty minutes or more as needed, not to exceed forty-five minutes per facility policy. 2. Patient Care Technician (PCT) reported abnormal findings to the Registered Nurse (RN) per facility policy. 3. Staff notified the physician of post weights above or below Estimated Dry Weight (EDW) per facility policy. This affected Patient Identifiers (PI) # 1, PI # 2, PI # 3, PI # 5, and PI # 4, in five of five MR reviews, and had the potential to affect all 51 patients dialyzing at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Date Published: 5/1/23 ...Data Collection Direct patient care staff may collect...weight, blood pressure (BP), pulse, respirations, temperature, general observations, access, and complaints reported by the patient. If the PCT notes any changes or abnormal findings in the patient’s condition or vascular access or reported by the patient...the RN must assess the patient. The RN will notify the patient’s physician/physician extender of any abnormal findings...based on clinical judgement for additional instruction. Pre-treatment Follow the steps for obtaining pre-treatment assessment data: Step 1: Weight Record the weight and compare to EDW. ...2. During Nursing rounds, RN will review the data collected...and assess the following parameters as needed... Data Collected Above Review the data collected above. Determine if any clinical interventions are necessary.... 3. Document findings and interventions in the MR. Contact the physician... for additional orders based upon assessment findings and clinical judgement. During Treatment: Obtain BP and pulse every thirty minutes or more as needed but not to exceed forty-five minutes... Document machine parameters and safety checks every thirty minutes or more often as needed but not to exceed forty-five minutes... Follow the steps below for monitoring patient and machine parameters during treatment: Step 1: Record BP. Recheck BPs after a drop that requires an intervention... Report to the nurse: Systolic blood pressure (SBP) greater than 180 millimeters of mercury (mm/Hg) Diastolic blood pressure (DBP) greater than 100 mm/Hg BPs less than or equal to 100 mm/Hg systolic Pulse below 60 or greater than 100 beats per minute ...Step 3: Machine Parameters and Extracorporeal Circuit Checked prescribed Blood Flow Rate (BFR) is being achieved... Check dialysate flow rate (DFR) setting is correct, and prescribed flow is being delivered. ...Observe and ensure that: ...Venous and arterial chambers are filled to the fill level. Post-Treatment Follow the steps for obtaining post-treatment assessment data: 1. ...obtain the following: Weight Obtain the patient’s post weight. Ensure the post weight is consistent with the goal... BP, pulse, respirations, temperature: Ensure vital signs and overall condition are stable for discharge. 2. Document findings on the patient’s record. Facility Policy: Patient Safety Event Reporting and Documentation Date Published: 2/6/23 ...Procedure Clinical Staff are required to report all Safety Events and Serious Safety Events to the patient’s physician. Below is a table ...event descriptions and definitions of Near Miss, Safety Events, and Serious Safety Events. Event Description Treatment Orders Not Met Definition: Dialysis Weight/UF Goal Variance Dialysis weight variance above or below the expected weight... 1. PI # 1 was admitted to the facility on 9/17/16 with the primary diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheets (TS) dated 4/3/25 and 4/24/25 revealed staff failed to obtain and document VS and safety checks every thirty minutes or more as needed, not to exceed forty-five minutes per facility policy. Review of the TS dated 4/1/25, 4/3/25, 4/5/25, 4/8/25, and 4/22/25 revealed the patient’s post treatment weight was above the EDW and staff failed to report the variance from the EDW to the patient’s physician. Review of the TS dated 4/8/25, 4/15/25, 4/16/25, 4/19/25, 4/26/25, 5/1/25, and 5/3/25 revealed staff failed to report SBPs greater than 180 mm/Hg, SBPs less than 100 mm/Hg, and diastolic DBPs greater than 100 mm/Hg to the RN. An interview was conducted on 5/8/25 at 12:19 PM with Employee Identifier (EI) # 3, Clinical Nurse Manager, who confirmed staff failed to obtain and document VS and safety checks every thirty minutes or more as needed, not to exceed forty-five minutes, report the patient’s post treatment weight to the patient’s physician, and report abnormal blood pressures to the RN per the facility policy. 2. PI # 2 was admitted to the facility on 4/5/22 with a primary diagnosis of ESRD. Review of the TS dated 4/10/25 and 4/17/25 revealed staff failed to obtain and document VS and safety check every thirty minutes or more not to exceed forty-five minutes per facility policy. Review of the TS dated 4/15/25 revealed staff failed to report DBP greater than 100 mm/Hg to the RN. An interview was conducted on 5/8/25 at 11:59 AM with EI # 3, who confirmed staff failed to obtain and document VS and safety checks every thirty minutes or more as needed, not to exceed forty-five minutes, and report abnormal blood pressures to the RN per facility policy. 30952 3. PI # 3 was admitted to the facility on 11/16/23 with diagnoses including ESRD. Review of the TS dated 3/11/25, 3/15/25, 3/20/25, 3/29/25, and 4/10/25 revealed staff failed to obtain and document VS and safety check every thirty minutes or more not to exceed forty-five minutes per facility policy. Review of the TS dated 3/19/25 revealed the ordered EDW 61.5 kg, pre-dialysis weight 68 kg, and post-dialysis weight 64.8 kg, which was 4.3 kg above EDW. There was no documentation the provider/physician was notified the post-dialysis weight. Review of the TS dated 3/20/25 revealed no documentation of the BFR/DFR from 1:30 PM to 3:46 PM, which was greater than 45 minutes. An interview was conducted on 5/8/25 at 11:44 AM with EI # 3 who confirmed staff failed to document VS, safety checks, and machine parameters at least every 45 minutes per policy, and notify the physician of the weight above the EDW. 4. PI # 5 was admitted to the facility on 10/14/24 with a diagnosis of ESRD. Review of TS’s dated 4/2/25, 4/7/25, 4/9/25, 4/18/25 revealed PI # 5’s pulse was below 60 beats per minutes. There was no documentation the PCT notified the RN the pulse was less than 60 per facility policy. Review of TS’s dated 4/7/25, 4/9/25, 4/14/25, 4/18/25, 4/21/25, 4/28/25 revealed the PCT documented the DBP was greater than 100 two or more times per treatment. There was no documentation the PCT notified the RN of the abnormal DBP. An interview was conducted on 5/8/25 at 12:24 PM with EI # 2, Director of Operations, and EI # 3, who confirmed the PCT failed to document and notify the nurse for abnormal vital signs per facility policy. 5. PI # 4 was admitted to the facility on 3/27/25 with a diagnosis of ESRD. Review of the TS’s dated 3/17/25, 3/25/25, 4/3/25, 4/8/25, 4/12/25, and 4/17/25 revealed vital signs and/or safety checks were not performed and documented at least every 45 minutes. An interview was conducted on 5/8/25 at 12:13 PM with EI # 3 who confirmed the staff failed to document vital signs and safety checks per the facility policy.”

“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: 49894 Based on review of medical records (MR), facility policies and procedure, and staff interview, it was determined the facility failed to ensure: 1. Staff followed the physician’s order for Blood Flow Rate (BFR). 2. Staff followed the physician’s order for Dialysate Flow Rate (DFR). 3. Staff reported treatment prescription variances to the physician. This affected Patient Identifiers (PI) # 1, PI # 2, PI # 5, PI # 3, and PI # 4, in five of five MR reviews and had the potential to affect all 51 patients dialyzing at the facility. Findings Include: Facility Policy: Patient Assessment and Monitoring Date Published: 5/1/23 ...During Treatment ...3. Machine Parameters and Extracorporeal Circuit. Check machine settings and measurements: Check prescribed blood flow is being achieved or reason documented if unable to meet the prescribed blood flow. Check DFR setting is correct, and the prescribed flow is being delivered... 4. Document any findings in the patient record. Facility Policy: Patient Safety Event Reporting and Documentation: Date Published: 2/6/23 ...Procedure Clinical Staff are required to report all Safety Events and Serious Safety Events to the patient’s physician. Below is a table ...event descriptions and definitions of Near Miss, Safety Events, and Serious Safety Events. Event Description Treatment Orders Not Met Definition: Incorrect BFR and/or DFR. Prescribed BFR/DFR not utilized for dialysis treatment. 1. PI # 1 was admitted to the facility on 9/17/16 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheet (TS) dated 4/29/25 revealed Hemodialysis (HD) Orders which included a BFR of 400. Further review of the TS dated 4/29/25 revealed the BFR was not as prescribed. There was no documentation in the medical record of why the BFR was not as prescribed or documentation the physician was notified of the prescription variance. Review of the TS dated 5/1/25 revealed HD Orders which included a DFR of 500. Further review of the TS dated 5/1/25 revealed the DFR was not as prescribed. There was no documentation in the medical record of why the DFR was not as prescribed or the physician was notified of the prescription variance. An interview was conducted on 5/8/25 at 12:19 PM with Employee Identifier (EI) # 3, Clinical Nurse Manager, who confirmed staff failed to deliver the BFR/DFR as prescribed and notify the physician of the prescription variance. 2. PI # 2 was admitted to the facility on 4/5/22 with a primary diagnosis of ESRD. Review of the TS dated 4/10/25 revealed HD Orders which included a BFR of 400 and DFR Autoflow 2.0 (800). Further review of the TS dated 4/10/25 revealed the BFR and DFR was not as prescribed and there was no documentation of why the BFR and DFR was not as prescribed. Further review of the TS dated 4/10/25 revealed there was no documentation the physician was notified of the prescription variance. An interview was conducted on 5/8/25 at 11:59 AM with EI # 3, who confirmed staff failed to deliver the BFR/DFR as prescribed and notify the physician of the prescription variance. 30952 3. PI # 5 was admitted to the facility on 10/14/24 with a diagnosis of ESRD. Review of the HD Orders dated 12/27/24 and 4/21/25 revealed orders for BFR 400 and manual DFR 800. Review of the TSs dated 4/2/25, and 4/14/25 revealed the BFR was not 400 as ordered. There was no documentation the physician was notified of the prescription variance. Review of the TS dated 4/7/25 revealed the manual DFR was not 800 as ordered. There was no documentation the physician was notified of the prescription variance. An interview was conducted on 5/8/25 at 12:24 PM with EI # 2, Director of Operations, and EI # 3, who confirmed the staff failed to deliver the dialysis BFR/DFR as ordered and notify the physician of the prescription variance. 4. PI # 3 was admitted to the facility on 11/16/23 with diagnoses including ESRD. Review of the TS dated 4/5/25 revealed HD orders for BFR 300 and DFR Autoflow 2.0 (600). Further review of the 4/5/25 TS revealed the BFR/DFR was not 300/600 as ordered. There was no documentation the physician was notified of the prescription variance. An interview was conducted on 5/8/25 at 11:44 AM with EI # 3 who confirmed staff failed to follow orders for BFR/DFR, and notify the physician of the prescription variance. 5. PI # 4 was admitted to the facility on 3/27/25 with a diagnosis of ESRD. Review of the TSs dated 3/17/25, 3/22/25, 3/25/25, 3/27/25, 4/3/25, 4/10/25, 4/12/25, 4/17/25 revealed HD Orders for BFR 400, DFR Autoflow 2.0 (800). Further review of the nine TSs above revealed the BFR and DFR was not 400/800 as ordered. There was no documentation the physician was notified of the prescription variance. An interview was conducted on 5/8/25 at 12:13 PM with EI # 3 who confirmed staff failed to follow orders for BFR/DFR, and notify the physician of the prescription variance.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 30952 Based on review of facility policy and procedure, facility Adverse (Safety) Events/ Report documentation, and interviews with patients and staff, it was determined the facility failed to ensure all reportable safety events identified were documented in the facility Safety Event Report system. This affected the 51 patients who dialyze at this facility, staff, and visitors. Findings include: Facility Policy and Procedure Title: Patient Safety Event Reporting and Documentation Published: 2/6/23 ...purpose of this policy is to provide guidelines for identifying, reporting, and documenting patient...Safety Events, and Serious Safety Events...Promote a culture of patient safety. ...Policy When a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event...Staff are responsible for timely completion of these policy requirements. Procedure Reporting of any patient event...should occur in person or verbally... Clinical Staff are required to report all Safety Events and Serious Safety Events... State and local agencies should be notified in accordance with applicable state regulations... ...Safety Event ...1. Clinical Staff to notify the Physician...complete documentation in the...Patient medical record, Patient Safety Data Entry Site... 2. Clinical Manager...to notify...State Reporting if applicable. ...Documentation...of all patient events shall be...Factual, complete, timely and concise...include that the physician was notified... Patient Safety Events should be reviewed during QAPI (quality assurance performance improvement) ...perform an analysis of all events...review of patient events by the QAPI Committee...Identify facility trends...Determine opportunities for improvement...by performing a Root Cause Analysis...Develop appropriate action plan... Categories, Events... Failure to Provide a Safe Patient Environment ...Unsafe Physical or Patient Care Environment...Unsafe physical or patient environment that...had the potential to result in patient injury. Examples include malfunctioning automatic doors... 1. Interviews were conducted on 5/6/25 on the patient treatment floor. An unsampled patient # 2 reported a complaint was made about two months ago to a Technician and Nurse, about an electric treatment floor door malfunction. The surveyor asked how the complaint was handled? The unsampled patient reported “...staff said it was fixed, it was not, and was told parts were on order. That was 2 months ago.” The patient confirmed she/he was not satisfied with how the facility had handled the treatment floor door repairs. Review of the facility Safety (Adverse) Events Report dated 5/7/24 to 5/7/25 failed to include documentation of the malfunction treatment floor door. An interview was conducted on 5/7/25 at 3:03 PM with Employee Identifier (EI) # 3, Clinical Nurse Manager, who reported the treatment door parts were on order. EI # 3 confirmed the door had been broken since March 2025. EI # 3 confirmed there was no documentation the malfunctioning treatment door, a patient care environment safety event, was entered into the facility safety reporting system. The failure to report and document all safety events prevent the QAPI Committee from analyzing all safety events, implementing corrective action, and evaluating process improvements. 2. Staff interviews were conducted on 5/6/25, 5/7/25, and 5/8/25. The surveyor asked direct care and management staff about a situation in which a firearm was discovered on the treatment floor. All staff confirmed a firearm was found by a direct care staff in a patient’s belongings, the patient finished the dialysis treatment that day and exited the treatment floor and facility. Review of the facility Safety (Adverse) Events Report dated 5/7/24 to 5/7/25 failed to include documentation of the safety event that had the potential to cause harm to patients, staff, and visitors. An interview was conducted on 5/7/25 at 3:03 PM with EI # 3 who confirmed staff failed to document the firearm discovery in the facility safety/adverse report system. The failure to report and document all safety events prevent the QAPI Committee from analyzing all safety events, implementing corrective action, and evaluating process improvements.”

“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: 30952 Based on facility policy, facility personnel documentation, and staff interviews, it was determined the facility failed to ensure staff followed the facility policy for weapons and firearms. This affected all 51 patients dialyzing at the facility, staff, and visitors. Findings include: Policy Title: Weapons and Firearms Published: 4/5/21 Purpose To safeguard the well-being of employees, patients, and visitors at all FKC (Fresenius Kidney Care) premises. Responsibility ...The Clinical Manager, Director of Operations (DO)...and Corporate Health, Safety, Environmental Affairs...Security and Risk Management should be immediately notified when a weapon is discovered in the facility. Policy ...Weapons prohibited: Within any FKC property... Weapons ...These include, but are not limited to: Guns... Any individual known to be carrying weapon...will not be allowed on FKC premises. Guidelines When a Weapon is Encountered In the unlikely event...the following guidelines should be followed: Step 1. If a weapon is present but not being used to intimidate or threaten anyone, and if feasible, request the individual to remove the weapon form FKC property. ...Violation of this policy may result in termination from employment for employees, involuntary discharge for patients or barring from the facility premises for visitors... Documentation of all actions taken should be made in all appropriate records...adverse events and/or human resources polices... Review of the facility Safety (Adverse) Events Report for 2024-2025 failed to include documentation of a safety event which involved discovery of a firearm on the patient treatment floor on 1/31/25. An interview was conducted on 5/6/25 at 1:47 PM with Employee Identifier (EI) # 11, Certified Clinical Hemodialysis Technician, who confirmed a couple of months ago, he/she discovered a gun in a patient’s bag during dialysis treatment. The surveyor asked EI # 11 what actions were taken upon discovery of the firearm. EI # 11 reported PI # 5 said it was not loaded, the dialysis treatment continued as scheduled, was completed, and the patient exited the treatment floor without incident. The surveyor asked EI # 11 what the facility policy was regarding firearms. EI # 11 response, “... they can’t come in the building.” EI # 11 stated he/she reported the firearm discovery to EI # 3, the Clinical Nurse Manager, a couple of days later. EI # 11 reported the patient still dialyzes at the facility. An interview was conducted on 5/7/25 at 3:03 PM with EI # 3, who reported he/she was working on the treatment floor on 1/31/25 but was not notified of the firearm discovery until 2/3/25, 3 days later. EI # 3 confirmed firearms were not allowed by policy on the premises. EI # 3 confirmed staff failed to immediately notify the manager of the safety threat and policy violation. Review of EI # 11’s personnel file did not include documentation coaching/counseling or discipline was conducted because of firearms/weapons policy noncompliance. An interview was conducted on 5/7/25 at 4:40 PM with EI # 2, DO, who reported there was no documentation EI # 11 received coaching/counseling or discipline for failure to immediately reporting the weapon per facility policy. EI # 2 confirmed staff failed to follow the facility Weapons and Firearms policy. There was no documentation an investigation of the firearm discovery was entered into the facility adverse event/safety system.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 49894 Based on patient and staff interviews, it was determined the facility failed to ensure staff maintained professional behavior on the hemodialysis treatment floor. This had the potential to affect all 51 patients dialyzing at the facility and employees of the facility. Findings include: Patient interviews were conducted on the hemodialysis treatment floor on 5/6/25 and 5/7/25. Eight patients interviewed stated they witnessed arguing between staff member # 1 and other staff, where yelling back and forth occurred on the treatment floor. Six of those patients stated they had also witnessed staff member # 1 be disrespectful to them and other patients, including arguing loudly when specific requests like where to cannulate their access, or requests to adjust machine settings due to feeling bad were made. These patients made other statements about staff member # 1 to include staff member # 1 had a bad attitude, they are rude, hard to work with, insensitive to their wishes, and that other employees had left the clinic (either transferred to another clinic or sought employment with other companies) due to this employee’s behavior. An interview was conducted on 5/7/25 at 2:19 PM with unnamed staff member # 2. Unnamed staff member # 2 confirmed the behavior on the treatment floor by staff member # 1 was rude and unprofessional. Unnamed staff member # 2 referred to staff member # 1’s behavior as...”bullying.” Review of the employee file of staff member # 1 did not reflect any re-education, counseling, coaching, or write-ups concerning complaints about their behavior on the treatment floor. An interview was conducted on 5/7/25 at 3:03 PM with Employee Identifier # 3, Clinical Nurse Manager, who confirmed he/she had received complaints about staff member # 1’s behavior on the treatment floor, there had been no investigation into the complaints, and there had been no re-education counseling, coaching, or write-ups concerning their behavior.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 49894 Based on review of the facility’s grievance policy, facility grievance log, and patient and staff interviews, it was determined the facility failed to document patient grievances and follow their own policy for the grievance submission, acknowledgement, investigation, review, response, and communication of patient grievances. This deficient practice did affect eleven unsampled patients had the potential to negatively affect all 51 patients dialyzing at the facility. Findings include: Facility Policy: Patient Grievance Date Published: 5/5/25 Purpose The purpose of this policy is to outline the steps involved in the grievance process and provide guidance on raising and resolving patient grievances within the organization. Policy A patient...may register a verbal or written complaint...directly or anonymously through the following channels... Any facility staff member, Clinical Manager (CM), or Director of Operations (DO), Corporate Clinical Services, Compliance Action Line, Staff Agency, End Stage Renal Disease Network. It is expected that all staff members will attempt to address and resolve complaints immediately, within the timeframe of the patient encounter. If immediate resolution cannot be achieved to the satisfaction of the patient, follow the steps in the procedure below... Responding to Grievances: Follow the process below when a patient or patient representative has reported a complaint. Step 1. Fresenius Kidney Care (FKC) staff promptly acknowledge the complaint and engage other staff members as appropriate (nurse in charge (CN), CM) in an attempt to resolve immediately. Step 2. If unable to resolve the complaint to the patient’s satisfaction within the current patient encounter, the CN must report as a grievance to the CM as soon as possible, preferably within 24 hours. Step 3. The CM will investigate the grievance and contact the patient within 3 business days, either verbally or in writing, to provide an update or resolution. The grievance will be recorded in the grievance log... Step 4. If the grievance is unable to be resolved by the CM, it must be escalated to the DO, preferably within 24 hours. Step 5. The DO will investigate the grievance and contact the patient within five business days...to provide an update or resolution. Step 6. If the grievance cannot be resolved by the DO, it must be escalated to the Regional Vice President (RVP), preferably within 24 hours. Step 7. The RVP will investigate the grievance and contact the patient within seven business days...to provide an update or resolution. Step 8. If the grievance remains unresolved at the RVP level, it must be escalated to the Governing Body (GB) for final resolution. Minutes of the GB meeting must include: Detailed description of the patient’s grievance, pertinent information regarding the grievance, response to the patient, description of the outcome. Step 9. If the GB requires further assistance...contact Clinical Services for additional support. 1. An interview was conducted on 5/6/25 at 9:25 AM with unsampled patient # 2, who reported a complaint was made about two months ago to a Technician and the Nurse, about an electric treatment floor door malfunction. The surveyor asked how the complaint was handled. The unsampled patient reported, “Staff said it was fixed, it was not, and was told parts were on order. That was 2 months ago.” The patient confirmed she/he was not satisfied with how the facility had handled the treatment floor door repairs. Review of the facility grievance log documentation dated 6/21/24 to 5/6/25 failed to include the patient grievance concerning the treatment floor door malfunction. An interview was conducted on 5/7/25 at 3:03 PM with Employee Identifier (EI) # 3, Clinical Nurse Manager, who reported the door had been broken for a couple of months. EI # 3 confirmed there was no documentation staff entered the treatment door complaint in the facility grievance system report. 2. An interview was conducted on 5/6/25 at 11:55 AM with unsampled patient # 1. The patient stated that after staff member # 1 infiltrated his/her arm during cannulation, a grievance was filed. The patient stated staff member # 1 continued to cannulate his/her access, even though the patient had expressed he/she did not want staff member # 1 to cannulate his/her graft. There was no documentation of this patient’s grievance on the facility’s grievance log dated 6/21/24 to 5/6/25. An interview was conducted on 5/7/25 at 3:03 PM with EI # 3, who confirmed there was no documentation on the grievance log. Staff failed to follow the facility’s policy for grievances. 3. An interview was conducted on 5/7/25 at 8:56 AM with unsampled patient # 3, who stated after he/she made suggestions of where to cannulate their access to staff member # 1, he/she was told by staff member # 1, “I’ve been doing this for more than twenty years.” The patient reported that staff member # 1 hurt him/her during cannulation, and he/she made a complaint and staff member # 1 continued to cannulate his/her access. There was no documentation of unsampled patient # 3’s complaint on the facility’s grievance log dated 6/21/24 to 5/6/25. An interview was conducted on 5/7/25 at 3:03 PM with EI # 3, who confirmed there was no documentation on the grievance log of this complaint. Staff failed to follow the facility’s policy for grievances. 4. An interview was conducted on 5/7/25 at 9:41 AM with unsampled patient # 4, who stated he/she had filed a grievance with the facility (documented in the grievance log on 4/25/25), concerning staff member # 1 cannulating his/her access. He/she stated he/she did not want the staff member to cannulate his/her access and recommended the entire staff be re-educated on the cannulation process. The grievance log reflected this, and EI # 3 agreed and documented in the grievance resolution/corrective actions that cannulation retraining would be arranged. An interview with was conducted on 5/7/25 at 3:03 PM with EI # 3, who confirmed there was no documentation cannulation retraining had been completed or scheduled per the grievance corrective actions, and the faciltity failed to follow its own policy for grievance resolution. 5. Seven patient interviews conducted on 5/6/25 and 5/7/25 had complaints of not getting on treatment at their scheduled time due to various issues that included hemodialysis machines malfunctioning and issues with the water system. These patients stated they have discussed this issue with staff and EI # 3. There was no documentation of these complaints on the grievance log. An interview was conducted on 5/7/25 at 3:03 PM with EI # 3, who confirmed all patient complaints were not documented in the facility’s grievance log. EI # 3 stated, the patients had made these complaints to him/her, and the complaints were discussed in the facility’s Quality Assurance Improvement meeting. EI # 3 stated the machines did not have enough hours to be replaced and the patient treatment chairs were not scheduled to be replaced.”