Fresenius Medical Care Louisa

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility’s emergency preparedness program failed to contain evidence of contacting the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. Findings: The facility policy’s titled, Guidelines for Emergency Preparedness, under the section “Local Emergency Operations Agency” reads, in part: “... Annually per procedure, the facility will contact their local disaster management agency to ensure that the agency is aware of the dialysis facility’s presence in the community in the event of an emergency...”. The policy was published 7/3/2023. During the review of the facility’s emergency preparedness (EP) plan, the state agency (SA) did not see documentation of the facility’s annual notification to the local EP agency informing the agency of the facility’s presence and needs in the event of an emergency. The SA inquired about the annual notification letter to the local EP agency. Employee (EMP) 1 advised there was a miscommunication between EMP1 and a previous biomedical technician regarding that letter and the annual water letter. It was discovered the annual EP letter had not been sent.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 42725 Based on observation and document review, it was determined the facility staff failed to remove expired medications and supplies from the emergency cart. Findings: The facility’s policy titled, Emergency Medications, Equipment and Supplies, under the section “Emergency Cart” reads, in part: “... The emergency cart must be: ... Checked monthly or after use for contents, expiration dates... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date...”. The policy was published 2/3/2025. During the flash tour on June 9, 2025, the SA conducted a review of the contents in the facility’s emergency cart and the following was discovered: Six (6) standard nasal cannulas - expired 10/19/2023, Nine (9) 21Gx1 Needles - expired 7/31/2023, Ten (10 10mL syringes - expired 7/31/2024, and Five (5) Glutose 15 oral glucose gel - expired 10/2022”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 42725 Based on medical record review, document review, and interview, it was determined the facility failed to provide evidence that emergency preparedness education was provided for the three sampled patients (MR1, MR2, and MR3). Findings: The facility’s policy titled, Guidelines for Emergency Preparedness, under the section “QAI Documentation” reads, in part: “Quarterly, all FKC patients must receive fire drill and emergency evacuation training. Training must be documented in QAI and on the fire drill attendance form. All drills: Fire, emergency evacuation, tabletop and community-based drill must be reviewed and documented in QAI”. Under the section labeled, Patient Education, it partly reads: “Facility staff must educate patients on: Evacuation procedures, Emergency Disconnection Procedures, Emergency Meal Plan, Facility Contact Information, Shelter Information, Transportation Information, and Emergency Preparedness... It is important for staff to engage patients in disasters drills and emergency procedures...”. The policy was published 7/3/2023. During the review of medical record (MR) 1, MR2, and MR3; the surveyor was unable to locate documentation of emergency preparedness education upon initial admission for MR1 and documentation indicating quarterly fire drill and emergency evacuation training was provided to MR2 and MR3. EMP1 assisted the SA by attempting to locate the documentation. The facility has experienced a change in staff and it was determined that the documentation may be been misfiled. EMP1 indicated the facility would ensure all patients are up to date with their emergency training and new documentation will be completed and filed.”

“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: 42725 Based on medical record review and document review, it was determined the facility failed to ensure patients were monitored during their treatments according to the policy; and acknowledge and verify abnormal vital signs obtained pre-treatment, during treatment, or post-treatment for the three patients sampled (MR1, MR2, and MR3). Findings: The facility’s policy titled, Patient Monitoring and Safety Checks During Hemodialysis Treatment, under the section title “Policy”, partly reads: “... Note: Patients must be under continual observation... Patient Monitoring. Monitor and document every 30 minutes or more frequently as needed but not to exceed 45 minutes per state regulations in the FKC Treatment Record. Patient Monitoring includes: Changes in the patient’s status, Blood pressure, pulse, respirations...”. The policy was published 9/5/2023. The facility’s policy titled, Patient Assessment and Monitoring, under the title “Data Collection”, partly reads: “Direct patient care staff may collect data such as weight, BP, pulse...”. Under the section labeled During Treatment, it partly reads: “Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes... Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes...”. Under the section titled “Pre-Treatment” and in the table labeled “Step” and “Action/Rationale” it partly reads: “... Blood pressure. Record blood pressure. Verify: Systolic blood pressures greater than 180mm/Hg and / or diastolic blood pressures greater than 100 mm/Hg, Systolic blood pressures less than or equal to 100 mm/Hg... Pulse. Record pulse. Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute...”. Under the section titled “During Treatment” and in the table labeled “Step” and “Action Rationale”, it partly reads: “1. Blood Pressure. Record blood pressure... Report to the nurse: Systolic blood pressures greater than 180 mm/Hg, Diastolic blood pressure greater than 100 mm/Hg, Blood pressure less than or equal to 100 mm/hg systolic. Pulse. Record pulse. 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 60, risen above 100 or become irregular...”. The policy was published 5/1/2023. MR1 5/31/2025 - Pre-treatment sitting blood pressure (BP) was 184/117 and standing BP was 189/118. During treatment, the following BPs were recorded: 186/100 and 184/98. 6/3/2025 - MR1 was monitored at 11:23 AM, the next monitoring documentation occurred at 12:33 PM. At 2:02 PM, vital signs were recorded. The next entry occurred at 2:58 PM. 6/5/2025 - During treatment, the following BPs were recorded: 192/103 and 190/108. 6/7/2025 - Pre-treatment sitting BP was 210/115. There was no standing BP recorded. During treatment, the following BPs were recorded: 205/113, 210/118, 195/111, and 198/109. There was no documentation indicating the nurse was notified of the elevated BP readings. MR2 5/29/2025 - Pulse obtained during pre-treatment was 50 R (regular). MR2’s pulse ranged between 40-47 during treatment. The post-treatment pulse was 44 IR (irregular). 6/3/2025 - Pulse obtained during pre-treatment was 49 R. The pulse ranged between 44-52 during treatment. The post-treatment pulse was 47 R. 6/5/2025 - Pulse obtained during pre-treatment was 44 R. The pulse ranged between 41-48 during treatment. The post-treatment pulse was 47 R. 6/7/2025 - Pulse obtained during pre-treatment was 43 R. The pulse ranged between 43-52 during treatment. The post-treatment pulse was 54 R. There was no documentation indicating the pulse was verified manually or that the nurse was notified of the rate. MR3 5/28/2025 - Pulse obtained during pre-treatment was 42 R. MR3’s pulse ranged between 37-45 during treatment. The post-treatment pulse was 37 R. A monitoring entry was recorded at 9:34 AM, the next entry occurred at 10:34 AM. 6/6/2025 - MR3’s pulse ranged between 38-53 during treatment. The post-treatment pulse was 46 R. 6/9/2025 - MR3’s pulse ranged between 40-52 during treatment. The post-treatment pulse was 42 R. There was no documentation indicating the pulse was verified manually or that the nurse was notified of the rate.”

“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: 42725 Based on medical record review and document review, it was determined the facility failed to follow the dialysis prescription for two (2) of the three (3) medical records sampled (MR2 and MR3). Findings: The facility’s policy titled, Patient Monitoring and Safety Checks During Hemodialysis Treatment, under the section title “Policy”, and under the heading “Safety Check - Machine Checks”, partly reads: “... Verify dialysate lines are attached and in correct position and DFR, BFR, and UFR is set and functioning per treating physician order...”. The policy was published 9/5/2023. The facility’s policy titled, Patient Assessment and Monitoring, under the section titled “During Treatment” and in the table labeled “Step” and “Action Rationale”, partly reads: “... Machine Parameters and Extracorporeal Circuit. Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered...”. The policy was published 5/1/2023. The medical record review revealed the following: MR2 The prescribed blood flow rate (BFR) is 400 and the dialysate flow rate (DFR) is autoflow 1.5 which equates to 600. The duration of treatment is 3 hours and 30 minutes. 5/29/2025 - The BFR ran at 450 and the DFR ran at 700 for approximately 3 hours of the treatment. 6/5/2025 - The BFR ran at 450 and the DFR ran at 700 for approximately 3 hours of the treatment. 6/7/2025 - The DFR ran at 800 for the length of treatment. There was no documentation indicating the reason for the variance. MR3 The prescribed BFR is 450 and DFR is Autoflow 2.0 which equates to 800. The duration of treatment is 3 hours 30 minutes. 6/9/2025 - The BFR was at 300 for 30 minutes and the DFR was at 600 for 41 minutes. There was no documentation indicating the reason for the variance.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 42725 Based on observation and document review, it was determined the facility staff failed to use aseptic technique when accessing an arteriovenous (AV) fistula/graft for three (3) of three (3) observations. Findings: The facility’s policy titled, Access Assessment and Cannulation, partly reads: “ ...Skin Disinfection...Step 2. Perform skin antisepsis on one site at a time, allow to dry and them {sic} cannulate. Do not touch cannulation sites after skin disinfection...”. The policy was published 5/6/24. During observations on June 9, 2025, the following was observed: At 12:06 PM, EMP5 was initiating treatment on a patient with an arteriovenous (AV) graft or fistula. EMP5 wiped the access area to disinfect; afterward and prior to cannulation, EMP5 touched the access site. EMP5 repeated this action for the second access site. EMP5 did not repeat skin cleansing after touching the “clean” access sites. At 12:13 PM, EMP3 was initiating treatment on a patient with an AV graft or fistula. EMP3 performed skin disinfection on the access site and immediately cannulated the site. There was no drying time in between the actions. The same process was followed for the second access site. At 12:32 PM, EMP5 initiated AV graft or fistula treatment on a patient. EMP5 repeated the same process as observed at 12:06 PM; cleansing the access sites, touching, and cannulating. Skin cleansing was not repeated after the access sites were touched and before cannulation occurred.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 42725 Based on interview, medical record review and facility document review, it was determined that facility staff failed to ensure the Plan of Care (POC) was signed by the patient for two (2) of the three (3) records reviewed (MR1 and MR2). Findings: The facility’s policy titled, Comprehensive Interdisciplinary Assessment and Plan of Care, partly reads: “...Comprehensive Assessment Participation and Plan of Care Review...- The patient must sign the plan of care meant to acknowledge the information in the plan. If the patient chooses not to sign their plan of care, the reason for the refusal must be documented in the patient’s medical record...”. The policy was published on 7/3/2023. Medical record review on June 10, 2025 evidenced that two of three patient records sampled had a POC that did not contain a signature from the patient. MR1’s POC dated 4/29/25 failed to document MR1’s signature or MR1’s refusal to sign. MR2’s POC dated 4/28/25 failed to document MR2’s signature or MR2’s refusal to sign. The SA inquired how it was determined that the POC was reviewed with the patient. EMP1 indicated that a patient signature is verification of the review.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to take action to ensure sustained improvement over time. Specifically, the QAPI program failed to correct known issues related to staff failing to follow the patient’s prescription for dialysis. The findings include: See Tag V-0544 Current Recertification Based on medical record review and document review, it was determined the facility failed to follow the dialysis prescription for two (2) of the three (3) medical records sampled (MR2 and MR3). Recertification Survey Ending June 2, 2022 Based on staff interview and document review, it was determined the facility failed to implement the prescribed dose of dialysis. Specifically, the facility failed to implement the prescribed blood flow rate (BFR) for one (1) of four (4) in-center dialysis patients in the survey sample.”