Fmc - Dialysis Institute of Anderson

“CFC-PERSONNEL QUALIFICATIONS CFR(s): 494.140 This Condition is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure color blindness testing was completed for 2 of 6 personnel records reviewed (PCT 7, 11) (See V0681), failed to ensure employes were qualified and competent to provide care for 5 of 6 personnel records reviewed. (PCT 2, 7, 9, 10, 11) (See V0694), failed to ensure initial and annual infection control training requirements were met for 2 of 6 personnel records reviewed (PCT 2, 9) (V0694), and clinical staff responsible for monitoring and testing of the water treatment system completed a training program and maintained documentation of this training for 4 of 6 employees. (PCT 2, 9, 10 and RN 7) (V0696). The cumulative effect of these systemic problems resulted in the facilities inability to ensure the provision of quality health care in a safe environment for the Condition for Coverage at §494.140 Condition: Personnel qualifications, with the likelihood to affect all 112 of the facilities active patients.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure that new and existing staff were provided with emergency preparedness training initially upon hire and annually for 3 of 3 personnel records reviews. (PCT 2, 7, 10) Findings Include: 1. A policy titled, “Progressive Renal Education Program (PREP) Orientation for Inexperienced New Employees” (05/23/2021 Version 3) indicated PREP provides new employees with initial and ongoing assessment of their knowledge and skills to include role specific training via classroom sessions, study guides, training materials, interactive distance learning, self-directed e-learning activities, and activities in the classroom and clinical practice setting. Success will be measured through demonstration, passing exams with score of 80% or higher, skills competency assessment, observed engagement and documented orientation. 2. A policy titled, “Knowledge, Skills and Competency Evaluation for Clinical Staff” (06/04/2024 Version 4) indicated clinical staff content includes role-specific training initially when hired and annually, as well as for one-time role specific training, knowledge evaluation and specific skills evaluation. Completion dates are entered in LMS for initial and annual exams and skills validation. 3. A personnel record review for PCT 2, date of hire 06/12/1995, failed to evidence initial and annual emergency preparedness training. 4. A personnel record review for PCT 7, date of hire 04/28/2025, failed to evidence cardiopulmonary resuscitation (CPR) training. 5. A personnel record review for PCT 10, date of hire 12/12/2015, failed to evidence initial and annual emergency preparedness training. 6. During an interview on 05/30/2025 at 9:32 AM, the Interim Clinical Manager indicated that there were documents that the facility was unable to locate therefore personnel files were being reviewed and updated with correct up to date documents. The facility recently upgraded the electronic personnel record keeping system from LMS to University and is unable to retrieve the previous information.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44230 Based on observation, record review, and interview, the facility failed to ensure staff completed adequate dialysis station disinfection to prevent the spread of communicable diseases for 1 of 2 station disinfection observations. (Station 7) Findings Include: 1. According to the “Cleaning and Disinfecting the Dialysis Station” policy (09/05/2023, Version 14), to prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient. 2. During an observation on 05/27/2025 at 10:00 AM, PCT 12 disinfected the dialysis machine prior to the previous patient vacating the treatment station. The first of two needles had been pulled from the dialysis access, and the patient was applying pressure to the site to promote clotting in the station chair. 3. During an interview on 05/27/2025 at 10:02 AM, PCT 12 indicated she was advised that she could disinfect the dialysis machine while the patient was holding his/her access sites but could not string the machine until after the chair was vacated. PCT 12 was unsure of what the policy stated. 4. During an interview on 05/27/2025 at 10:25 AM, RN 8 (Entity 2) indicated that patients should vacate station chairs prior to any disinfection or set-up for the next patient. 5. During an interview on 05/30/2025 at 9:30 AM, the Interim CM indicated she is addressing the infection control concerns found during the survey with all staff as part of the plan of correction.”

“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: 44230 Based on observation, record review, and interview, the facility failed to ensure adequate disinfection of the CVC catheter limbs using an alcohol pad for 1 of 1 CVC initiations. (Patient #5) Findings Include: 1. According to the “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer” policy (05/05/2025, Version 9), use a sterile alcohol pad to scrub the sides and end of the hub thoroughly with friction for 10-15 seconds. 2. During an observation on 05/28/2025 at 11:30 AM, PCT 13 removed the cap of the arterial CVC and disinfected with an alcohol pad for 5 seconds then proceeded to remove the cap of the venous CVC and disinfected with an alcohol pad for 6 seconds. 3. During an interview on 05/28/2025 at 11:38 AM, PCT 13 indicated the policy was to disinfect the CVC catheter limbs for 3-5 seconds each using an alcohol pad. 4. During an interview on 05/30/2025 at 9:30 AM, the Interim CM indicated she is addressing the infection control concerns found during the survey with all staff as part of the plan of correction.”

“POC-MONITOR ESA RESPONSE CFR(s): 494.90(a)(4) The patient’s response to erythropoiesis-stimulating agent(s), including blood pressure levels and utilization of iron stores, must be monitored on a routine basis. This Standard is not met as evidenced by: 44230 Based on record review and interview, the facility failed to ensure the health and safety of patients related to failure to monitor response to an erythropoiesis-stimulating agent for 1 of 8 patients reviewed. (Patient #6) Findings Include: 1. A policy titled, “Patient Safety Event Reporting and Documentation” (02/06/2023 Version 2) indicated a list of near misses, safety events, and serious safety events included that included allergic reaction to medications. When an allergic reaction to a medication occurs, clinical staff are to notify the CM & Biomed/Technical Services if applicable. Clinical staff will also perform documentation in the patient medical record, the Patient Safety Data Entry site, to be reviewed during Quality Assessment and Performance Improvement (QAPI). Documentation of all patient events shall be factual, complete, timely and concise. Include patient assessment and represent an accurate recording of the events, times, interventions, and result of interventions. Any conversations with the patient that are relevant to the event should be documented to include the physician was notified. The clinical staff most familiar with the event is responsible for documenting. A successful review of patient the event will be performed by QAPI to include developing an appropriate action plan, ensuring proper documentation, and ensuring appropriate departments have been reported to. 2. A document titled, “Mircera [medication used to treat anemia] Medication or Pre-Filled Syringe Reporting Decision Tree” (08/2023) indicated with a suspected patient Mircera reaction, without a required hospitalization or emergency care, a Mircera Medication or Pre-Filled Syringe form should be completed, notify Vifor via email/fax (an adverse event reporting system), and enter the event in Patient Safety Data Entry site. 3. A policy titled, “Management and Prevention of Anaphylaxis or Allergic Reaction (Adult)” (07/01/2024, Version 8) indicated the CM is to be notified. Immediately discontinue the medication to reduce or eliminate the reaction, notify the provider with the patient condition and seek orders for further intervention. Complete factual, concise documentation in the clinical record to include a patient assessment with accurate recording of events, times, and interventions with results. Any conversations with the patient relevant to the event should be documented and actual language used by the patient should be quoted exactly where relevant. Enter and update allergies in the patient ’ s medical record per policy and enter the event in Patient Safety Data Entry System. 4. A document titled, “Patient Transfer 1481-Anderson” (05/28/2025) for Patient #6 evidenced a list of 18 medication allergies. Mircera failed to be included on his/her allergy list. 5. A document titled, “Adverse Events Report” dated 05/27/2024 - 05/27/2025 indicated a list of reported adverse events for all patients of the facility in the past year. The list failed to include Patient #6 ’ s adverse reaction to a Mircera injection received on 05/03/2025. 6. A 05/15/2025 treatment sheet for Patient #6, indicated the previous dose of Mircera, 50 micrograms (mcg) was administered on 05/03/2025. A nursing note entered by RN 7 indicated the patient voiced that she had a bad reaction to her last dose of Mircera. No other details were documented to include symptoms/outcomes. The physician was notified, and orders were received to contact Patient #6 ’ s hematologist. 7. A 05/17/2025 treatment sheet for Patient #6, failed to list Mircera as an allergy as reported by the patient on 05/15/2025. The treatment sheet also included documentation of Patient #6 receiving a second dose of Mircera, 50 mcg at 12:04 PM on 05/17/2025, administered by RN 1. No further documentation regarding the Mircera administration was found on the treatment sheet. 8. A 05/20/2025 treatment sheet for Patient #6 failed to list Mircera as an allergy as reported by the patient on 05/15/2025. 9. A 05/22/2025 treatment sheet for Patient #6 failed to list Mircera as an allergy as reported by the patient on 05/15/2025. 10. During an interview on 05/29/2025 at 10:07 AM, the Interim CM indicated that Patient #6 should not have received a second dose of Mircera on 05/17/2025 after reporting an allergic reaction from the previous dose on 05/15/2025. She further indicated the physician and clinical services should have been made aware and MIrcera should have been listed as an allergy in the patient ’ s medical record. She will provide me with a policy of all other actions that should be taken with medication allergies. 11. During an interview on 05/29/2025 at 11:10 AM, RN 1 indicated that Patient #6 received a first dose of Mircera on 05/03/2025 and a second dose on 05/17/2025. 12. During an interview on 05/30/2025 at 10:20 AM, Patient #6 indicated he/she was administered Mircera on 05/03/2025, a first dose, and experienced uncontrollable jerking motions, almost throwing her phone across the room during treatment. He/she was unaware that a second dose was administered on 05/17/2025 and does not recall having any similar reaction or other symptoms. Paatient #6 should have been made aware a second dose of Mircera was administered prior to receiving it but may not have refused it. He/she has a diagnosis of Multiple Sclerosis diagnosis that could have contributed to her uncontrollable jerking but was unsure with the new dose of Mircera just administered. 13. During an interview on 05/29/2025 at 10:46 AM, RN 7 indicated that she made a note in the Patient #6 ’ s chart with what the patient thought was an allergic reaction to the Mircera dose administered on 05/03/2025. RN 7 indicated that the Patient #6 discussed cramping as the side effect experienced. RN 7 did not add Mircera to the patient allergy list because it was unclear if it was a true allergy or a side effect or submit an adverse event. It was indicated that the procedure is to notify the physician, clinic manager, and add the documentation and allergy to the patient ’ s medical record. RN 7 did indicate that the nephrologist (kidney specialist) was notified who provided orders to notify the patient ’ s hematologist (medical doctor specializing in diagnosing, treating, and preventing blood disorders) and was awaiting a reply for further instructions. To date there has been no reply from the hematologist and no follow up by staff. 14. During an interview on 05/29/2025 at 11:00 AM, RN 1 indicated that she administered the Mircera dose on 05/03/2025 and Patient #6 did not voice any complaints at that time. She administered the second dose of Mircera on 05/17/2025. It was brought to her attention that the patient had an issue after taking the first dose. She indicated that she had a discussion with the patient and educated the patient on risk vs. benefits. RN 1 indicated she failed to chart the conversation but should have, failed to list Mircera as an allergy or intolerance, and failed to document the patient ’ s reaction as an adverse event.”

“H-TRAIN CONTENT INCLUDES ER PREP HOME PTS CFR(s): 494.100(a)(3) The training must- (3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas: (i) The nature and management of ESRD. (ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician’s prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient’s plan of care. (iii) How to detect, report, and manage potential dialysis complications, including water treatment problems. (iv) Availability of support resources and how to access and use resources. (v) How to self-monitor health status and record and report health status information. (vi) How to handle medical and non-medical emergencies. (vii) Infection control precautions. (viii) Proper waste storage and disposal procedures. This Standard is not met as evidenced by: 44230 Based on record review and interview, the home dialysis department failed to monitor and educate the patient on safe treatment related to pulse and blood pressure (BP) rates for 1 of 1 home hemodialysis treatments reviewed. (Patient #10) Findings Include: A document titled, “ProviderHub Note HHD Results Report” (05/13/2025), a physician note, indicated Patient #10 blood pressures are in the 90’s and 100’s systolic with heart rates in the low 100’s. The patient has a heart monitor due to increased pulse with activity. A document titled, “Clinical Notes Report” (05/19/2025), RN 2 indicated the physician was made aware of Patient #10’s elevated heart rate and is wearing a heart monitor ordered by the cardiologist. A document titled, “Clinical Notes Report” (05/9/2025), a home visit by RN 2 with vital signs stable for Patient #10, heart rate regular, tachycardia (increased pulse) with standing. Home treatment sheets dated 05/07/2025 - 05/26/2025 indicated the following BP/pulse rates for Patient #10: 05/07/2025 Pretreatment BP 87/48 (standing) Intradialytic (during dialysis) 82/48 at 11:18 AM and 80/45 at 11:37 AM Post treatment BP 81/56 & pulse 129 (standing) Dialysis Center Notes indicated “none” 05/08/2025 Pretreatment pulse 111 (sitting), 116 (standing) Intradialytic BP: 7:41 PM 86/48, 7:56 PM 86/53 Post treatment pulse 114 (sitting), 117 (standing) Dialysis Center Notes indicated “none” 05/09/2025 Pretreatment BP 72/47 (sitting) Intradialytic BP: 81/45 at 1:11 PM and 78/49 at 1:33 PM Post treatment BP 83/45 (sitting) Dialysis Center Notes indicated “none” Patient Notes indicated at 1:36 PM Ultrafiltration (UF) (fluid being pulled) at 0. 05/11/2025 Pretreatment BP 88/50 (standing) Post treatment BP 88/52 & pulse 114 (standing) Dialysis Center Notes indicated “none.” 05/12/2025 Pretreatment BP 89/44 (sitting) & pulse 116 (standing) Post treatment BP 84/50 & pulse 118 (sitting) and BP 78/45 & pulse 121 (standing) Dialysis center notes indicated attempts to obtain a weight chair due to recent ankle injury. 05/14/2025 Pretreatment BP 83/56 (standing) Intradialytic BP: 74/45 at 11:08 AM, 76/44 at 11:18 AM, 73/46 at 11:25 AM, 77/48 at 11:29 AM, and 82/47 at 12:37 PM Post treatment BP 80/44 (sitting), 88/44 (standing) Patient Notes indicated at 11:08 AM the patient turned off the UF and administered 100 milliliters of saline (medication used to increase fluid volume & increase BP). Dialysis center notes indicated “none”. 05/16/2025 Pretreatment pulse 112 (sitting), 117 (standing) Intradialytic BP 83/42 at 8:37 PM & 87/48 at 8:56 PM Dialysis center notes indicated “none”. 05/19/2025 Intradialytic BP: 82/50 at 7:38 PM, 88/47 at 8:08 PM, 80/45 at 8:40 PM Post treatment (sitting) BP 87/42, (standing) 80/42 Dialysis center notes indicated “none”. 05/22/2025 Pretreatment BP 84/48 (standing) Dialysis center notes indicated “none”. 05/23/2025 Post treatment (standing) BP 84/47, pulse 122 and (sitting) pulse 117 Dialysis center notes indicated “none”. 05/25/2025 Intradialytic BP: 88/50 at 8:08 PM Post treatment (sitting) BP 86/50, (standing) pulse 114 Dialysis center notes indicated “none”. 05/26/2025 Pretreatment BP (standing) 72/45 Dialysis center notes indicated “none”. During an interview on 05/29/2025 at 10:45 AM, RN 2, the home hemodialysis nurse, indicated she does not document abnormal findings on the home hemodialysis treatment sheets, any documentation would be found in the clinical notes that will be provided. When asked, RN 2 could not provide appropriate BP and pulse parameters for home hemodialysis patients to know if it was safe to start/continue treatment or when to notify the facility. RN 2 indicated the physician is aware of Patient #10’s chronic low blood pressure and pulse rates and would provide documentation. She further indicated that Patient #10’s health status has deteriorated significantly since a post hospitalization/rehabilitation stay from an ankle injury that required surgery. During an interview on 05/27/2025 at 12:54 PM, the SW indicated that Patient #10 recently had an extended hospital stay related to an ankle injury that required surgery and chronically has a low blood pressure and elevated pulse rate. His/her health has deteriorated, and the facility plans to complete an unstable care plan June 2025. During an interview on 05/28/2025 at 9:15 AM, the RD indicated Patient #10 was admitted to the hospital on 04/16/2025 - 05/01/2025, then to a Long-Term Acute Care (LTAC) from 05/01/2025 -05/13/2025 for a fall at home that ended with an ankle fracture and surgery. This injury is the reason for her recent decline. The daughter completes all his/her hemodialysis treatments. The facility ’ s plan is to complete an unstable care plan for Patient #10 June 2025. During an interview on 05/30/2025 at 11:00 AM RN 3 indicated that Patient #10 was admitted to the hospital on 04/16/2025-05/01/2025 for a fall in the home that resulted in an ankle fracture requiring surgery. Patient #10 resumed facility home treatments on 05/02/2025. RN 2 completes home hemodialysis oversight and could not answer any specific questions.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure personnel qualification requirements for color blindness testing were completed for 2 of 6 personnel records reviewed (PCT 7, 11). Findings Include: Color Blindness Testing 1. According to the “Color Blindness Testing” policy (01/23/2019, Version 3), new hires, rehires, or transfer staff working in a direct patient care or biomedical position are required to take the Ishihara Test for Color Blindness to ensure the ability to perform the essential functions of their jobs. 2. A personnel record review for PCT 7, date of hire 04/28/2025, failed to evidence color blindness testing. 3. A personnel record review for PCT 11, date of hire 01/06/2025, failed to evidence color blindness testing. 4. During an interview on 05/30/2025 at 11:40 AM, PCT 11 indicated a color blindness test was more than likely done upon, but hire was unsure. 5.During an interview on 05/30/2025 at 11:50 AM, RN 1 indicated that color blindness testing is to be completed upon hire and staff should not be completing water testing prior to passing a color blindness test. 6. During an interview on 05/30/2025 at 9:32 AM, the Interim CM indicated that color blindness testing should be completed with water room check-off. This varies depending on where staff are in the training process but typically between week 8 - 12.”

“PQ-PCT-TRAINING PROGRAM CONTENT CFR(s): 494.140(e)(3) The training program must include the following subjects: (i) Principles of dialysis. (ii) Care of patients with kidney failure, including interpersonal skills. (iii) Dialysis procedures and documentation, including initiation, proper cannulation techniques, monitoring, and termination of dialysis. (iv) Possible complications of dialysis. (v) Water treatment and dialysate preparation. (vi) Infection control. (vii) Safety. (viii) Dialyzer reprocessing, if applicable. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure personnel qualifications to include initial and annual competencies were documented and/or ensure initial and annual infection control training requirements were met for 5 of 6 personnel records reviewed (PCT 2, 7, 9, 10, 11). Findings Include: Orientation/ Continuing Education 1. A policy titled, “Progressive Renal Education Program (PREP) Orientation for Inexperienced New Employees” (05/23/2021 Version 3) indicated PREP provides new employees with initial and ongoing assessment of their knowledge and skills to include role specific training via classroom sessions, study guides, training materials, interactive distance learning, self-directed e-learning activities, and activities in the classroom and clinical practice setting. Success will be measured through demonstration, passing exams with score of 80% or higher, skills competency assessment, observed engagement and documented orientation. 2. A policy titled, “Knowledge, Skills and Competency Evaluation for Clinical Staff” (06/04/2024 Version 4) indicated clinical staff content includes role-specific training initially when hired and annually, as well as for one-time role specific training, knowledge evaluation and specific skills evaluation. Completion dates are entered in LMS for initial and annual exams and skills validation. 3. A personnel record review of PCT 2, date of hire 06/12/1995, failed to evidence orientation upon hire and annual continuing education. A document titled “Enterprise Training Report” dated 05/29/2025 evidenced PCT 2 had been assigned “Infection Prevention Fundamentals” and it was past due. The personnel record reviewed for PCT 2 failed to evidence initial infection control training and continued infection control training. 4. A personnel record review of PCT 7, date of hire 04/28/2025, failed to evidence orientation upon hire. 5. A personnel file review of PCT 9, date of hire 07/18/2018, failed to evidence orientation upon hire and annual continuing education. A document titled “Enterprise Training Report” dated 05/29/2025 evidenced PCT 9 had been assigned “Infection Prevention Fundamentals” and it was past due. The personnel record review for PCT 9 failed to evidence initial infection control training and continued infection control training. 6. A personnel file review of PCT 10, date of hire 12/12/2015, failed to evidence orientation upon hire and annual continuing education. During an interview on 05/30/2025 at 11:45 AM, PCT 10 indicated that role-specific orientation is required upon hire with competencies completed annually. During an interview on 05/30/2025 at 11:45 AM, PCT 10 indicated that infection control training is to be completed upon hire and annually. 7. A personnel file review of PCT 11, date of hire 01/06/2025, failed to evidence orientation upon hire. During an interview on 05/30/2025 at 11:40 AM, PCT 11 indicated that she completed infection control training upon hire and staff are constantly being educated on infection control. During an interview on 05/30/2025 at 11:40 AM, PCT 11 indicated that trainings are in LMS and that it was completed after she was hired. 8. During an interview on 05/30/2025 at 9:32 AM, the Interim Clinical Manager indicated that there were documents that the facility was unable to locate therefore personnel files were being reviewed and updated with correct up to date documents. The facility recently upgraded the electronic personnel record keeping system from LMS (electronic learning system) to University and are unable to retrieve the previous information. 9. During an interview on 05/30/2025 at 11:50 AM, RN 7 indicated that infection control training is ongoing, but staff complete yearly trainings in LMS.”

“PQ-H20 TREATMENT SYSTEM TECHS TRAINING CFR(s): 494.140(f) Technicians who perform monitoring and testing of the water treatment system must complete a training program that has been approved by the medical director and the governing body. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure clinical staff responsible for monitoring and testing of the water treatment system completed initial and/or annual training as required for 4 of 6 personnel records reviewed. (PCT 2, 9, 10 and RN 7) Findings Include: 1. According to the “Carbon Filtration Monitoring for Incenter Central Water Systems” policy (05/05/2025, Version 12), Fresenius Kidney Care staff monitoring carbon filter performance must have documented evidence of the following: completion of initial and annual water training. 2. A policy titled, “Progressive Renal Education Program (PREP) Orientation for Inexperienced New Employees” (05/23/2021 Version 3) indicated PREP provides new employees with initial and ongoing assessment of their knowledge and skills to include role specific training via classroom sessions, study guides, training materials, interactive distance learning, self-directed e-learning activities, and activities in the classroom and clinical practice setting. Success will be measured through demonstration, passing exams with score of 80% or higher, skills competency assessment, observed engagement and documented orientation. 3. A policy titled, “Knowledge, Skills and Competency Evaluation for Clinical Staff” (06/04/2024 Version 4) indicated clinical staff content includes role-specific training initially when hired and annually, as well as for one-time role specific training, knowledge evaluation and specific skills evaluation. Completion dates are entered in LMS (electronic learning system) for initial and annual exams and skills validation. 4. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that PCT 2 completed total chlorine checks on 03/01/2025, 03/04/2025, 03/13/2025, 03/15/2025, 03/24/2025, 03/25/2025, 03/27/2025, and 03/29/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that PCT 2 completed total chlorine checks 04/01/2025, 04/03/2025, 04/08/2025, 04/12/2025, 04/22/2025, 04/24/2025, 04/25/2025, and 04/26/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/30/2025, indicated that PCT 2 completed total chlorine checks on 05/06/2025, 05/10/2025, 05/17/2025, 05/20/2025, 05/27/2025 without evidence of proper competency. A personnel record review for PCT 2, date of hire 06/12/1995, failed to evidence initial and annual water room training. 5. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that PCT 9 completed total chlorine checks on 03/03/2025, 03/08/2025, 03/10/2025, 03/12/2025, 03/13/2025, 03/18/2025, 03/19/2025, 03/26/2025, and 03/31/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that PCT 9 completed total chlorine checks 04/05/2025, 04/14/2025, 04/15/2025, 04/24/2025, and 04/28/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/30/2025, indicated that PCT 9 completed total chlorine checks on 05/02/2025, 05/03/2025, 05/05/2025, 05/07/2025, 05/12/2025, 05/13/2025, 05/16/2025, 05/17/2025, 05/19/2025, 05/21/2025, 05/23/2025, 05/26/2025, and 05/28/2025 without evidence of proper competency. A document titled “DPC Skills Validation” dated 10/04/2021, for PCT 9 evidenced the last completed annual water training on 10/04/2021. 6. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that PCT 10 completed total chlorine checks on 03/04/2025, 03/07/2025, 03/08/2025, 03/11/2025, 03/12/2025, and 03/17/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that PCT 10 completed total chlorine checks 04/03/2025, 04/05/2025, 04/08/2025, 04/10/2025, 04/11/2025, 04/17/2025, 04/24/2025, and 04/29/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/30/2025, indicated that PCT 10 completed total chlorine checks on 05/01/2025, 05/08/2025, 05/09/2025, 05/14/2025, 05/22/2025, 05/23/2025, 05/27/2025, and 05/28/2025 without evidence of proper competency. A document titled “DPC Skills Validation” dated 01/09/2023 for PCT 10 evidenced the last completed annual water training on 01/09/2023. 7. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that RN 7 completed total chlorine checks 03/01/2025, 03/04/2025, 03/06/2025, 03/07/2025, 03/10/2025, 03/13/2025, 03/15/2025, 03/15/2025, 03/18/2025, 03/20/2025, 03/21/2025,03/27/2025, 03/28/2025, 03/29/2025, and 03/31/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/01/2025, indicated that RN 7 completed total chlorine checks 04/01/2025, 04/03/2025, 04/04/2025, 04/07/2025, 04/10/2025, 04/14/2025, 04/17/2025, 04/18/2025, 04/19/2025, 04/21/2025, 04/24/2025, 04/26/2025, and 04/29/2025 without evidence of proper competency. A document titled “FKC Log Readings Report for Total Chlorine” dated 05/30/2025, indicated that RN 7 completed total chlorine checks on 05/01/2025, 05/02/2025, 05/05/2025,05/08/2025, 05/10/2025, 05/13/2025, 05/15/2025, 05/16/2025, 05/19/2025, 05/20/2025, 05/22/2025, 05/24/2025, 05/28/2025, 05/29/2025, and 05/30/2025 without evidence of proper competency. A document titled “DPC Skills Validation” dated 01/09/2023 for RN 7 evidenced the last annual water training completed was on 01/09/2023. 8. During an interview on 05/30/2025 at 9:32 AM, the Interim CM indicated that there were personnel documents that the facility was unable to locate therefore personnel records were being reviewed and updated with correct up to date documents. The facility recently upgraded the electronic personnel record keeping system from LMS to University and are unable to retrieve the previous information. 9. During an interview on 05/30/2025 at 11:45 AM, PCT 10 indicated that water training is required upon hire with additional annual competencies to be completed. Initial training was completed per policy, but annual training was completed today due to missing information in the new e-learning system. 10. During an interview on 05/30/2025 at 11:50 AM, RN 7 indicated water room training is completed upon hire and then annually and must be completed prior to completing water room tasks. Water testing completed every 4 hours require 2 staff members, an RN and a PCT. The Biomed is responsible for checking staff off.”

“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: 51751 Based on observation, record review, and interview, the medical director failed to ensure staff followed policy and procedures to include washing accesses prior to dialysis cannulation (inserting needles) for 1 of 2 AVF observations (Patient #8), Tuberculosis (TB) (airborne infection) policy for 4 of 6 personnel files reviewed, (PCT 2, 7, 10, and RN 7) expired supplies for 1 of 1 home facility observed, incorrect physician ordered blood flow rates (BFR) for 5 of 8 in-center hemodialysis records reviewed (Patient #1, 4, 5, 6, 7) and 1 of 4 in-center hemodialysis treatment observations (Patient #12) and patient blood pressure (BP) and/or pulse checks for 7 of 10 records reviewed (Patient #1, 2, 3, 5, 6, 7, 8) Findings Include: Washing Access Arm 1. According to the “Access Assessment and Cannulation” policy (05/05/2025, Version 5), prior to treatment, ask patient to wash access area with soap and water, per hand hygiene procedure. If the patient is unable to wash their own access, the staff or care partner should wear gloves to wash the patient’s access with soap and water. 2. During an observation on 05/27/2025 at 9:40 AM, PCT 9 failed to wash the AVF access site with soap and water prior to cannulating or reminding Patient #8 to wash his/her access at the sink. 3.During an interview on 05/27/2025 at 9:51 AM, PCT 9 indicated she did not wash the cannulation site with soap and water for Patient #8 because he/she washed the access at the sink prior to sitting down in the dialysis station. 4. During an interview on 05/27/2025 at 9:55 AM, Patient #8 indicated he does not wash his access arm prior to cannulation and doesn’t need to because he doesn’t “use that gooey stuff” referring to a EMLA cream (a gel like substance used on AVF and AVG accesses to numb the cannulation area). 5. During an interview on 05/27/2025 at 11:10 AM, Patient #11 indicated he/she does not wash his access arm prior to dialysis because staff clean it with an alcohol pad. He/she was unsure what sink patients would use to wash their hands or access. Expired Supplies 1. According to the “Storage of Supplies” policy (04/05/2021, Version 2), supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire, appropriately disposing of items that have reached the expiration date. 2. During an observation in the Home Department on 05/27/2025 at 9:51 AM, 20 vials of sterile water, with an expiration date of 04/01/2025, were found in the medication cabinet. 3. During an observation in the Home Department on 05/27/2025 at 10:03 AM, a CultureSwab Plus collection and transport system, with an expiration date of 05/11/2025, was found in the lab drawer. 4. During an interview on 05/27/2025 at 9:59 AM, RN 2 indicated that all staff are responsible for checking for expired supplies and medications prior to use. 5. During an interview on 05/27/2025 at 10:10 AM, RN 2 indicated that the lab area was checked last week for expired supplies, but they could have missed something. Incorrect BFR’s 1. According to the “Patient Assessment and Monitoring” policy (05/01/2023, Version 4), staff are to check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow. 2. During an observation of the treatment room on 05/28/2025 at 11:00 AM, Patient #12’s active treatment evidenced a BFR of 400 despite the physician’s order for 450, without documenting a reason for the deviation. During an interview on 05/28/2025 at 11:00 AM, RN 7 indicated that patient #12 should be running a BFR of 450 and was unsure why he/she was running at 400 as there was no reason documented. RN 7 indicated that if a BFR is not running as ordered, staff are to document the reason and notify the nurse. 3. A treatment sheet dated 05/23/2025 for Patient #1 indicated a physician prescribed BFR of 400. Patient #1 ran 350 for the entire treatment without documentation of the deviation from the prescribed value and/or RN notification. 4. A treatment sheet dated 05/24/2025 for Patient #4 indicated a physician prescribed BFR of 450. Patient #4 ran 300 for the entire treatment without documentation of the deviation from the prescribed value and/or RN notification. 5. A treatment sheet dated 05/23/2025 for Patient #5 indicated a physician prescribed BFR of 500. Patient #5 ran 375 for the entire treatment without documentation of the deviation from the prescribed value and/or RN notification. 6. A treatment sheet dated 05/15/2025 for Patient #6 indicated a physician prescribed BFR of 400. Patient #6 ran a BFR of 350-375 for the entire treatment without documentation of the deviation from the prescribed value and/or RN notification. 7. A treatment sheet dated 05/16/2025 for Patient #7 indicated a physician prescribed BFR of 450. Patient #7 ran a BFR of 300-435 for greater than 3 hours of treatment without documentation of the deviation from the prescribed value and/or RN notification. A treatment sheet dated 05/23/2025 for Patient #7 indicated a physician prescribed BFR of 450. Patient #7 ran a BFR of 300 for the entire treatment without documentation of the deviation from the prescribed value and/or RN notification. 8. During an interview on 05/30/2025 at 11:40 AM, PCT 11 indicated that if the BFR is changed the RN should be notified and the reason documented. 9. During an interview on 05/30/2025 at 11:50 AM, RN 7 indicated that if patients are not running as prescribed, the PCT is expected to notify the RN and document the reason. Late blood pressure/pulse checks 1. According to the “Patient Assessment and Monitoring” policy (05/01/2023, Version 4), during treatment staff are to obtain blood pressure and pulse every 30 minutes or more as needed but not to exceed 45 minutes or per states regulations. 2. The clinical record for Patient #1 was reviewed and evidenced the following: A treatment sheet dated 05/14/2025 indicated a BP and pulse check completed at 7:21 AM with a subsequent BP & pulse check completed at 8:30 AM. A treatment sheet dated 05/23/2025 indicated a BP & pulse check completed at 9:33 AM with a subsequent BP & pulse check completed at 10:27 AM. 3. The clinical record for Patient #2 was reviewed and evidenced the following: A treatment sheet dated 05/16/2025 indicated a BP & pulse check completed at 4:34 PM with a subsequent BP & pulse check completed at 5:33 PM. 4. The clinical record for Patient #3 was reviewed and evidenced the following: A treatment sheet dated 05/21/2025 indicated a BP & pulse check completed at 11:32 AM with a subsequent BP & pulse check completed at 12:32 PM. A treatment sheet dated 05/26/2025indicated a BP & pulse check completed at 10:35 AM with a subsequent BP & pulse check completed at 11:33 AM. 5. The clinical record for Patient #5 was reviewed and evidenced the following: A treatment sheet dated 04/25/2025 indicated a BP & pulse check completed at 11:43 AM with a subsequent BP & pulse check completed at 12:43 PM. A treatment sheet dated 05/02/2025 indicated a BP & pulse check completed at 11:41 AM with a subsequent BP & pulse check completed at 12:39 PM. A treatment sheet dated 05/23/2025 indicated a BP & pulse check completed at 12:23 PM with a subsequent BP & pulse completed at 1:35 PM and BP & pulse check completed at 2:04 PM with a subsequent BP & pulse completed at 3:05 PM. 6. The clinical record for Patient #6 was reviewed and evidenced the following: A treatment sheet dated 05/20/2025 for Patient #6 indicated a BP & pulse check completed at 2:04 PM with a subsequent BP & pulse completed at 3:02 PM. A treatment sheet dated 05/22/2025 indicated a BP & pulse check completed at 2:00 PM with a subsequent BP & pulse completed at 3:00 PM. 7. The clinical record for Patient #7 was reviewed and evidenced the following: A treatment sheet dated 05/23/2025 for Patient #7 indicated a BP & pulse check completed at 9:04 AM with a subsequent BP & pulse completed at 10:05 AM. 8. The clinical record for Patient #8 was reviewed and evidenced the following: A treatment sheet dated 05/22/2025 indicated a BP & pulse check completed at 10:32 AM with a subsequent BP & pulse completed at 11:32 AM. A treatment sheet dated 05/26/2025 indicated a BP & pulse check completed at 12:23 PM with a subsequent BP & pulse completed at 1:15 PM. 9. During an interview on 05/30/2025 at 11:40 AM, PCT 11 indicated that blood pressure and pulse checks should be done every 30 minutes unless out of range than every 15 minutes. 10. During an interview on 05/30/2025 at 11:50 AM, RN 7 indicated that blood pressure and pulse checks depend on the patient but not to exceed every 30 minutes. TB Testing 1. According to the “Employee Tuberculosis Testing” policy (05/05/2025), Tuberculosis testing using the two-step tuberculin skin test (TST) method is required upon hire. If a new employee has a documented baseline TST result within the previous 12 months, a single TST can be administered as this additional TST represents the second stage of the two-step testing. IF an employee provides Interferon-Gamma Release Assay (IGRA) results, these results can be accepted upon hire if the results are within the previous 12 months and interpreted by the ordering physician. A recent chest x-ray within the previous 6 months can be used as evidence to exclude diagnosis of Tuberculosis (TB) in employees with positive TST. 2. A personnel record review for PCT 2, date of hire 06/12/1995, failed to evidence an initial two-step TST upon hire, a TST within the last 12 months, an IGRA result, or a recent chest x-ray excluding a diagnosis of TB. 3. A personnel record review for PCT 7, date of hire 04/28/2025, failed to evidence an initial two-step TST upon hire, a TST within the last 12 months, an IGRA negative result, or a recent chest x-ray excluding a diagnosis of TB. 4. A personnel record review for PCT 10, date of hire 12/12/2015, evidenced a one-step TST administered by the facility on 12/22/2015. The facility failed to administer a second-step TST or provide evidence that PCT 10 had a previous test within the previous 12 months. 5. A personnel record review for RN 7, date of hire 01/28/2019, evidenced a one-step TST administered by the facility on 01/30/2019. The facility failed to administer a second-step TST or provide evidence that RN 7 had a previous test within the previous 12 months. 6. During an interview on 05/30/2025 at 11:40 AM, PCT 11 indicated that she received a two-step TST when she was hired but is unsure what the requirements are or what the policy indicates. 7. During an interview on 05/30/2025 at 11:50 AM, RN 7 indicated that staff are to receive a two-step TST when they are hired and complete an annual TB risk assessment. 8. During an interview on 05/30/2025 at 11:45 AM, PCT 10 indicated a one-time 1st step TB test was administered upon hire and did not receive the 2nd step. She is unaware of the requirement upon hire. An annual risk assessment is to be completed annually.”

“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: 45607 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff wore personal protective equipment (PPE) per facility policy during dialysis discontinuation with a fistula for 1 of 1 Patient Care Technician (PCT) observed (PCT 1). Findings include: 1. The Personal Protective Equipment policy indicated “Employees shall use personal protective equipment in accordance with the type of patient contact expected and anticipated exposure ... Personal protective equipment, including a full-face shield or mask and protective eyewear ... must be worn to protect employees from blood or other potentially infectious materials ... PPE is used ... when performing procedures during which spurting or spattering of blood might occur (eg., during initiation and termination of dialysis ...).” 2. During an observation on 5/22/24 at 10:41 AM, PCT 1 discontinued dialysis treatment for Patient #6. PCT 1 had her face shield pushed back on her head and tilted up in such a way that her face was not covered by the shield. PCT 1 failed to wear her face shield in a manner to cover the eyes, nose, and mouth. 3. During an interview on 5/22/24 at 11:03 AM, RN 1 relayed if face shields are used as PPE during the discontinuation of dialysis, they should cover the nose and mouth.”

“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: 45607 Based on record review and interview, the dialysis facility failed to ensure patients were assessed and/or monitored per policy for 2 of 5 patient records reviewed (Patient #1, #2) and failed to ensure blood pressures (BP) and/or pulse rates outside of established parameters were reported to the registered nurse (RN) for 2 of 2 patient records reviewed with BP and/or pulse rats outside of parameters (Patient #1, #2). Findings include: 1. The Patient Assessment and Monitoring policy, revised 5/01/23, indicated that during treatment staff is to “Obtain blood pressure and pulse rate every 30 minutes or more often as needed but not to exceed 45 minutes ... Reposition electronic cuff or use a manual cuff for aberrant blood pressure readings ... Report to the nurse ... Systolic blood pressures greater than 180 ... Diastolic blood pressure greater than 100 ... Blood pressure less than or equal to 100 ... systolic ... Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute ... Report to the nurse patients whose heart rates have dropped below 60x, risen above 100 or become irregular ...” 2. The Hypertension policy, dated 9/07/21, indicated “Staff will recognize, report, and immediately address systolic blood pressures greater than 180 ... and/or diastolic blood pressures greater than 100 ...” 3. Review of Patient #1’s ICHD treatment sheets, dated 5/06/24 to 5/20/24, evidenced the following: On 5/15/24, the ICHD treatment began at 11:19 AM. The treatment sheet indicated the following: at 12:32 PM, the BP was 206/90. The clinical record failed to evidence the nurse was notified of the elevated blood pressure. On 5/10/24, the ICHD treatment began at 11:19 AM. The treatment sheet indicated the following: at 12:32 PM, the pulse rate was 46. The clinical record failed to evidence the nurse was notified of the BP. The BP was checked at 1:36 PM and next checked at 2:33 PM, 57 minutes later. The dialysis facility failed to ensure BP was checked every 30 minutes. During an interview on 5/24/24 at 1:19 PM, PCT 3 indicated she did not know why she didn’t click the report to RN button, but that BP should be taken every 30 minutes. During an interview on 5/24/24 at 1:57 PM PCT 4 indicated pulse below 60 should be reported to the RN and documented in the clinical record. The PCT indicated they would have rechecked the pulse rate but must have not charted the recheck. PCT 4 further indicated she didn’t know why there was a missed BP check on 5/10/24, that she was just helping out. During an interview on 5/24/24 at 2:15 PM, PCT 5 indicated the missing BP check on 5/10/24 was around break time and that she has a patient who goes on treatment right around that time so she probably missed it wasn’t done. On 5/13/24, the ICHD treatment began at 11:17 AM. The treatment sheet indicated the following: at 11:19 AM, the BP was 185/111. The clinical record failed to evidence the RN was notified of the elevated blood pressure. During an interview on 5/24/24 at 2:15 PM, PCT 5 indicated systolic BP greater than 180 and diastolic BP above 100 should be reported to the RN. PCT 5 further indicated that Patient #1 had an ankle cuff so they would often get odd numbers and indicated she probably should have reported the elevated BP at 11:19 AM. At 12:44 PM, the BP was 222/109. The clinical record failed to evidence the RN was notified of the elevated BP. During an interview on 5/24/24 at 1:44 PM, PCT 1 indicated she would have notified the nurse but that it looks like she didn’t chart it. On 5/17/24, the ICHD treatment began at 11:16 AM. The treatment sheet indicated the following: a BP check was performed at 2:37 PM with the next BP check at 3:34 PM, 57 minutes later. The dialysis facility failed to ensure BP checks were performed every 30 minutes. During an interview on 5/24/24 at 2:15 PM, PCT 5 indicated it the BP check was probably missed due to putting on patients and getting busy. 4. Patient #2’s ICHD treatment sheets, dated 5/07/24 to 5/21/24, were reviewed and evidenced the following: On 5/07/24, the ICHD treatment began at 10:43 AM. The treatment sheet indicated the following: at 11:30 AM, the BP was 94/74. The clinical record failed to evidence the RN was notified of the low blood pressure. During an interview on 5/24/24 at 12:55 PM, PCT 6 indicated it looked like she forgot to click notified RN regarding the low BP.”