Fresenius Medical Care of Windsor

“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: 26622 Based on facility policy review, observations, and staff interviews, the facility staff failed to prevent potential cross contamination by failing to ensure a clean field was placed under the CVC Central Venous Catheter) limbs in one of two observation during a discontinuation of a CVC (PCT #4, Station #1) Findings included: Review on 09/24/2025 of the facility policy titled “Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer,” published 11/04/2024 revealed “... Prior to Termination: Preparation ... Step 5. Ensure that a clean underpad is below the catheter limbs to protect the work area and the clothing. ... Termination: Disinfection of Catheter and Disconnecting the Patient ... Step 6 ...NOTE: Do not place uncapped catheter limbs on underpad to prevent contamination. 7. Hold the limb while allowing the antiseptic to dry. ...” Observation on 09/24/2025 at 1150 on the treatment floor revealed PCT #4 discontinued a hemodialysis treatment with Central Venous Catheter at Station #1. PCT #4 donned clean gloves, disconnected the extracorporeal lines from the CVC , without placing a new clean under pad under the CVC limbs. Observation revealed the facility policy was not followed. Interview on 09/24/2025 at 1200 with the Operations Director revealed that the staff were expected to place a clean underpad under the catheter limbs prior to beginning the termination of the treatment to prevent cross contamination. The interview revealed that the facility staff failed to follow the facility policy for discontinuing a Central Venous Catheter.”

“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: 26622 Based on facility policy review, medical record reviews, and staff interview, the facility staff failed to monitor a patient at a minimum of every 30-45 minutes during hemodialysis treatments for 3 of 7 sampled in-center hemodialysis records reviewed (Patient #1, #2 and #4). Findings included: Review on 09/24/2025 of the facility policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed, “... During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations.” 1. Open medical record review on 09/24/2025 for Patient #1 revealed a 57-year-old male admitted to the facility for ICHD (In-Center Hemodialysis) treatments on 06/16/2025. Review of the treatment sheet dated 09/15/2025 revealed the treatment started at 0839 and ended at 1239 for a duration of 240 minutes. Review of the monitoring documentation dated 09/15/2025 revealed Patient #1’s blood pressure, pulse and machine parameters were monitored by staff at 0839 and monitored next by staff at 0929 (50 minutes later). The next monitoring by staff was completed at 1024 (55 minutes later). Review of the treatment sheet dated 09/19/2025 revealed the treatment started at 0825 and ended at 1153 for a duration of 208 minutes. Review of the monitoring documentation dated 09/19/2025 revealed Patient #1’s blood pressure, pulse and machine parameters were monitored by staff at 0859 and monitored next by staff at 0956 (57 minutes later). Review of the monitoring documentation revealed vital signs and machine parameters were monitored at 1055 and monitored next by staff at 1153 (58 minutes later). Review revealed the facility staff failed to monitor the patient’s blood pressure, pulse and machine parameters at least every 30-45 minutes during the hemodialysis treatment on 09/15/2025 and 09/19/2025. Interview on 09/24/2025 at 1600 with the Operations Director revealed the staff were expected to monitor the patients every 30-45 minutes during treatments. Interview revealed the staff monitored vital signs, machine parameters, visualized the access sites, and checked for wet transducers. Interview revealed the staff should have documented the monitoring in the patient’s treatment record. Interview revealed the staff failed to follow the facility policy. 2. Open medical record review on 09/24/2025 for Patient #2 revealed a 65-year-old female admitted to the facility for ICHD treatments on 08/27/2025. Review of the treatment sheet dated 09/15/2025 revealed the treatment started at 1250 and ended at 1644 for a duration of 234 minutes. Review of the monitoring documentation dated 09/15/2025 revealed Patient #2’s blood pressure, pulse and machine parameters were monitored by staff at 1251 and monitored next by staff at 1339 (48 minutes later). Review of the treatment sheet dated 09/20/2025 revealed the treatment started at 1023 and ended at 1431 for a duration of 248 minutes. Review of the monitoring documentation dated 09/20/2025 revealed Patient #2’s that no machine parameters were monitored by staff from 1324 through 1432 (68 minutes). Review revealed the facility staff failed to monitor the patient’s blood pressure, pulse and machine parameters at least every 30-45 minutes during the hemodialysis treatment on 09/15/2025 and 09/20/2025. Interview on 09/24/2025 at 1600 with the Operations Director revealed the staff were expected to monitor the patients every 30-45 minutes during treatments. Interview revealed the staff monitored vital signs, machine parameters, visualized the access sites, and checked for wet transducers. Interview revealed the staff should have documented the monitoring in the patient’s treatment record. Interview revealed the staff failed to follow the facility policy. 3. Open medical record review on 09/24/2025 for Patient #4 revealed a 55-year-old female admitted to the facility for ICHD treatments on 01/27/2023. Review of the treatment sheet dated 09/20/2025 revealed the treatment started at 1015 and ended at 1315 for a duration of 180 minutes. Review of the monitoring documentation dated 09/20/2025 revealed Patient #4’s blood pressure, pulse and machine parameters were monitored by staff at 1028 and monitored next by staff at 1132 (64 minutes later). The next monitoring by staff was completed at 1233 (61 minutes later). Review revealed the facility staff failed to monitor the patient’s blood pressure, pulse and machine parameters at least every 30-45 minutes during the hemodialysis treatment on 09/20/2025. Interview on 09/24/2025 at 1600 with the Operations Director revealed the staff were expected to monitor the patients every 30-45 minutes during treatments. Interview revealed the staff monitored vital signs, machine parameters, visualized the access sites, and checked for wet transducers. Interview revealed the staff should have documented the monitoring in the patient’s treatment record. Interview revealed the staff failed to follow 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: 26622 Based on policy review, medical records review, and staff interviews, the facility staff failed to follow the adequacy plan of care by not dialyzing 4 of 7 (Patients #1, #2, #4 and #6) in-center hemodialysis patients at the prescribed Blood Flow Rate (BFR)/Dialysate Flow Rate (DFR) and/or treatment duration. Findings include: A review on 08/14/2025 of the facility’s policy and procedure, “Patient Assessment and Monitoring,” published 05/01/2023, revealed “Purpose ...Responsibility ...Definitions ...Delegation ...Data Collection ...Pre-Treatment ...During Treatment ...Step 1 ...Step 3 [space] Machine Parameters and Extracorporeal Circuit [space] 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. ...” A review on 08/14/2025 of the facility’s policy and procedure, “Unable to Achieve Prescribed Blood Flow Rate,” published 11/01/2021, revealed “Purpose ...Responsibility ... Background ...Policy (space) Staff ... will recognize and report to the nurse in charge the inability to achieve prescribed blood flow rate ... Documentation (space) Document in patient’s treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physician orders. ...” 1. Review on 09/24/2025 of the medical record for Patient #1 revealed a 57-year-old male that had been admitted to the facility for in-center hemodialysis (ICHD) treatment on 06/16/2025. A review of the Physician orders revealed Patient #1’s Dialysate Flow Rate (DFR) was ordered at 800 with a treatment duration order for 4 hours (hrs). Review of the Treatment Flowsheet dated 09/15/2025 revealed Patient #1’s hemodialysis treatment was initiated at 0839 and ended at 1239 for a duration of 4 hrs. Review of the Flowsheet revealed Patient #1’s DFR average was 450, with no documentation for the decreased DFR and no documentation of the Registered Nurse notification. Review of the Treatment Flowsheet dated 09/19/2025 revealed Patient #1’s hemodialysis treatment was initiated at 0825 and ended at 1153 for a duration of 3 hrs and 28 min (shortened by 32 minutes) with no evidence of an AMA (Against Medical Advice) form completed. Interview on 09/24/2025 at 1600 with the Operations Director revealed that the facility nursing staff were expected to obtain a signed AMA (Against Medical Advice) form for every patient that received a shortened treatment duration or document the patient’s refusal to sign on the AMA form. The interview revealed that the patient care technicians were expected to notify the nursing staff anytime they increased and/or decreased the patient’s DFR and document in the medical record. The interview revealed that the nursing staff should have assessed and documented the reason for the decreased DFR during the patient’s treatment. 2. Review on 09/24/2025 of the medical record for Patient #2 revealed a 65-year-old female that had been admitted to the facility for in-center hemodialysis (ICHD) treatment on 08/27/2025. A review of the Physician orders revealed Patient #2’s Blood Flow Rate (BFR) was ordered at 400 with a treatment duration order for 4 hours (hrs). Review of the Treatment Flowsheet dated 09/20/2025 revealed Patient #2’s hemodialysis treatment was initiated at 1023 and ended at 1431 (4 hrs and 8 mins). Review of the Flowsheet revealed Patient #2’s BFR average was 340, with no documentation for the decreased BFR and no documentation of the Registered Nurse notification. Interview on 09/24/2025 at 1600 with the Operations Director revealed that the patient care technicians were expected to notify the nursing staff anytime they increased and/or decreased the patient’s BFR, or if they were unable to achieve the ordered BFR. The interview revealed that the nursing staff should have assessed and documented the reason for the decreased BFR during the patient’s treatment. 3. Review on 09/24/2025 of the medical record for Patient #4 revealed a 55-year-old female that had been admitted to the facility for in-center hemodialysis (ICHD) treatment on 01/27/2023. A review of the Physician orders revealed Patient #4’s Dialysate Flow Rate (DFR) was ordered at 800 with a treatment duration order for 3 hours (hrs). Review of the Treatment Flowsheet dated 09/18/2025 revealed Patient #4’s hemodialysis treatment was initiated at 1007 and ended at 1312 for a duration of 3 hrs and 5 mins. Review of the Flowsheet revealed Patient #4’s DFR average was 540, with no documentation for the decreased DFR and no documentation of the Registered Nurse notification. Review of the Treatment Flowsheet dated 09/20/2025 revealed Patient #4’s hemodialysis treatment was initiated at 1015 and ended at 1315 for a duration of 3 hrs. Review of the Flowsheet revealed Patient #4’s DFR average was 600, with no documentation for the decreased DFR and no documentation of the Registered Nurse notification. Interview on 09/24/2025 at 1600 with the Operations Director revealed that the patient care technicians were expected to notify the nursing staff anytime they increased and/or decreased the patient’s DFR and document in the medical record. The interview revealed that the nursing staff should have assessed and documented the reason for the decreased DFR during the patient’s treatment. 4. Review on 09/24/2025 of the medical record for Patient #6 revealed a 70-year-old male that had been admitted to the facility for in-center hemodialysis (ICHD) treatment on 01/11/2019. A review of the Physician orders revealed Patient #6’s Dialysate Flow Rate (DFR) was ordered at 800 with a treatment duration order for 3 hours (hrs) and 15 mins. Review of the Treatment Flowsheet dated 09/15/2025 revealed Patient #6’s hemodialysis treatment was initiated at 0605 and ended at 0929 for a duration of 3 hrs and 24 mins. Review of the Flowsheet revealed Patient #6’s DFR average was 510, with no documentation for the decreased DFR and no documentation of the Registered Nurse notification. Interview on 09/24/2025 at 1600 with the Operations Director revealed that the patient care technicians were expected to notify the nursing staff anytime they increased and/or decreased the patient’s DFR and document in the medical record. The interview revealed that the nursing staff should have assessed and documented the reason for the decreased DFR during the patient’s treatment.”

“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: 26622 Based on policy and procedure review, observations, and staff interviews, the facility failed to ensure staff performed skin antisepsis per policy before cannulation of 2 of 2 Arterio-venous fistula/graft (AVF/AVG) cannulation procedures observed (Station #10, PCT #1; Station #3, PCT #4). Findings include: Review on 09/24/2025 of the facility policy “Access Assessment and Cannulation,” Published: 05/05/2025, revealed “... Assessment of Vascular Access ... Skin Disinfection Step 1 Disinfect cannulation site as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulation. ...” 1. Observation on 09/23/2025 at 1020 in the patient treatment area, revealed PCT #1 entered Station #10 and prepared to access the patient’s AVF/AVG. Observation revealed PCT #1 donned clean gloves and applied antiseptic (70% isopropyl alcohol pad) to each access site over the skin in a concentric circle for less than 10 seconds. The observation revealed the PCT failed to clean each access site for 30 seconds per facility policy. Interview on 09/23/2025 at 1150 with PCT #1 revealed that PCT #1 verbalized the appropriate cleaning time for the cannulation of access sites. Interview revealed PCT #1 did not use the second hand on the available treatment floor clocks. Interview revealed PCT #1 failed to clean/disinfect each of the access sites for 30 seconds, prior to cannulation and securing the needles. Interview revealed PCT #1 failed to follow the facility policy. Interview on 09/23/2025 at 1200 with the Operations Director revealed the staff were expected to disinfect each access site for 30 seconds when using alcohol pads. Interview revealed the PCT did not follow the facility policy. 2. Observation on 09/24/2025 at 1000 in the patient treatment area, revealed PCT #4 entered Station #3 and prepared to access the patient’s AVF/AVG. Observation revealed PCT #4 donned clean gloves and applied antiseptic (70% isopropyl alcohol pad) to the area over both access sites at the same time for less than 30 seconds. Observation revealed PCT #4 failed to clean each access site for 30 seconds per facility policy. Interview on 09/24/2025 at 1015 with PCT #4 revealed that PCT #4 verbalized the appropriate cleaning time for the cannulation of access sites. Interview revealed PCT #4 failed to clean/disinfect each of the access sites for 30 seconds, prior to cannulation and securing the needles. Interview revealed PCT #4 failed to follow the facility policy. Interview on 09/24/2025 at 1200 with the Operations Director revealed the staff were expected to disinfect each access site for 30 seconds when using alcohol pads. Interview revealed the PCT did not follow the facility policy.”