Fresenius Medical Care Midwest South

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 29972 Based on observation and interview, staff failed to ensure that clean supplies are stored in clearly designated clean areas and not near potentially contaminated supplies and blood samples in 2 of 2 observations of clamp storage containers (clean and dirty clamps), in a total sample of 2 clamp storage containers observed. Findings Include: On 01/21/2026 beginning at 10:00 AM observed multiple “clean” blue and white clamps in an empty bucket, uncovered on top of a cart. Per observations, there was another bucket of “dirty” clamps soaking in a bleach solution on the bottom of the same cart allowing for potential cross contamination of clean supplies; the clamps were stationed right across from the blood lab storage area and “dirty” sink. Per interview with Registered Nurse (RN) C on 01/21/2026 at 11:35 AM, the white and blue clamps on the top of the cart were “clean” and the clamps in the bucket on the bottom of the cart were “dirty.” Per interview with RN A on 01/23/2026 at 1:00 PM, the clean clamps should be covered and stored in a designated clean area to prevent cross contamination.”

“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: 29972 Based on observation, interview, and record review staff failed to clean and disinfect all the equipment at the dialysis station between patients to prevent cross contamination in 1 of 2 observations of dialysis station cleaning (Station (St) #13), in a total sample of 2 observations of station cleaning, and failed to clean and disinfect the Hoyer lift after use in 1 of 2 observations of the Hoyer lift used for a patient (Patient (Pt) #5), in a total sample of 2 observations of staff using the Hoyer lift. Findings Include: Review of policy and procedure #47806 Version 15 titled, “Cleaning and Disinfecting the Dialysis Station” published 09/02/2025 revealed: - “A dialysis station must be cleaned and disinfected between dialysis patients.” - Dialysis Stations: “Area including the dialysis machine, chair, and other reusable equipment or supplies utilized during dialysis treatment...Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine and attachments such...hand sanitizer/holder...” On 01/21/2026 beginning at 10:15 AM, observed Patient Care Technician (PCT) D cleaning and disinfecting St #13; PCT D did not clean the following: - Dialysate hoses attached to the dialysis machine - Sharps container attached to the dialysis machine - Crevices between the arm rest and tray table (fold down tray table) On 01/21/2026 beginning at 10:56 AM, Observed PCT E and PCT H using a Hoyer lift to transfer Pt #5 to the treatment chair. PCT E returned the Hoyer lift to the clean supply area without cleaning and disinfecting the Hoyer lift after use. During interview with Clinic Manager A on 01/23/2026 beginning at 1:00 PM, Manager A stated that the above areas should be cleaned during the station disinfection. Manager A stated that the Hoyer lift should be cleaned after use and before returning to a clean area.”

“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: 29972 Based on observation, interview, and record review staff failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination in 1 of 4 patients observed with a CVC (Patient (Pt) #4) in a total sample of 4 patients observed with a CVC. Findings include: Review of policy and procedure #45664 titled, “Changing the Catheter Dressing Procedure” Published 02/05/2024 Version 8, revealed: -If using 2% Chlorhexidine and 70% alcohol (Chloraprep): “Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle...” On 01/21/2026 beginning at 1:40 PM observed Patient Care Technician (PCT) G performing Pt #4’s CVC dressing change. PCT G held Pt #4’s shirt collar and proceeded to scrub the skin under the shirt, allowing the shirt to touch the skin after cleaning. PCT G did not secure Pt #4’s shirt properly to prevent potential cross contamination. During interview with Clinic Manager A on 01/23/2026 beginning at 1:00 PM, Manager A stated that staff should secure the shirt away from the CVC exit site while performing the dressing change.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 29972 Based on observation, record review and interview, staff failed to ensure the facility was safe from potential infection control risks in 4 of 5 Home training rooms observed (Room #1, #2, #3, #5), in a total of 5 Home training rooms observed. Findings Include: Review of policy and procedure #47685 version 9 titled, “General Cleanliness and Infection Control Guidelines” published 09/02/2025 revealed, “All areas must be kept clean and organized...facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility.” Observations on 01/21/2026 beginning at 3:35 PM of Home training rooms #1, #2, #3, and #5 (Peritoneal Dialysis and Home Hemodialysis) revealed there was a large amount of brown residue and splatter in the cabinets under the sink. Per observations in room #2, there were two 2 liter bags of 1.5% Dextrose in the cabinet under the sink. Per interview with Clinic Manager B on 01/21/2026 at 3:40 PM, Manager B observed the findings and stated that the cabinets should be clean. Per Manager B, the bags of Dextrose solution should not be under the sink. Manager B stated that the Biomedical Technician is responsible for inspecting the Home training rooms to identify issues such as these. During interview with Area Technical Operations Manager (ATOM) I beginning on 01/22/2026 at 10:28 AM, ATOM I stated that the Biomedical Technician does not conduct regular inspections of the Home training area.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 29972 Based on record review and interview staff failed to ensure Heparin is administered as per physician orders in 3 of 5 in-center hemodialysis patients with Heparin orders (Patients (Pt) #6, #9, #10), in a total sample of 10 medical records reviewed. Findings include: Review of policy and procedure titled, “Use of a Heparin Pump Procedure” Published 08/03/2020 Version 4, revealed, “In the heparin screen on the dialysis machine set the treatment parameters for the rate and infusion time...Note: It is recommended the heparin pump be stopped: 30-60 minutes prior to the end of treatment in accordance with a physician order on patients dialyzing through a fistula or graft.” Review of Pt #6’s Treatment Sheet dated 01/21/2026 revealed an order for Heparin infusion via pump of 500 units per hour during dialysis treatment and turn off pump 0 minutes prior to the end of treatment. Review of Pt #6’s Treatment Sheet revealed the Heparin pump was started at 10:04 AM and stopped at 12:31 PM (2 hours 27 minutes) and “Total Infused” was documented as 0.400 milliters (400 units). Pt #6 should have received approximately 1225 units of heparin (500 units x 2.45 hours) as per physician orders, not 400 units as documented. Review of Pt #9’s Treatment Sheet dated 01/14/2026 revealed an order for Heparin infusion via pump of 500 units per hour during dialysis treatment; per orders the pump should be stopped 60 minutes prior to the end of treatment. Review of Pt #9’s Treatment Sheet revealed dialysis treatment ended at 5:54 PM and the Heparin pump was stopped at 5:51 PM (3 minutes prior to the end of treatment). Review of Pt #10’s Treatment Sheet dated 01/21/2026 revealed an order for Heparin infusion via pump of 1500 units per hour during dialysis treatment; per orders the pump should be stopped 60 minutes prior to the end of treatment. Review of Pt #10’s Treatment Sheet revealed dialysis treatment ended at 6:54 PM and the Heparin pump was stopped at 6:53 PM (1 minute prior to the end of treatment). During interview with Clinic Manager A on 01/23/2026 beginning at 1:00 PM, Manager A confirmed findings and stated that the Heparin pump is manually programmed by staff and that the total infused and Heparin pump stop times should be completed as per physician orders.”

“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: 29972 Based on record review and interview, staff failed to ensure that the nursing assessments/evaluations address fluid management needs post dialysis treatment in 3 of 10 records reviewed (Patients (Pt) #7, #8, #10); and failed to perform nursing assessments when the blood pressure is out of parameters as per policy in 2 of 10 medical records reviewed (Pt #9, #10), in a total sample of 10 medical records reviewed. Findings include: Review of policy and procedure #45265 titled, “Nursing Supervision and Delegation” Version 6 Published 11/06/2023 revealed: - “Prior to discharge the Registered Nurse (RN) must review the treatment record to confirm...Whether the patient is achieving dry weight and identify reason for patient not achieving dry...” - “The Team Leader/Charge Nurse will use their clinical judgement based on individual patient needs to determine if any clinical interventions are necessary.” - “RN should address “Any post treatment weight with a variance from the estimated dry weight of 1.0 kg.” - “Prior to discharge the Registered Nurse (RN) must review the treatment record for whether the patient is achieving dry weight and identify reason for patient not achieving dry weight; and blood pressures <100 systolic or greater than 180 systolic (normal 120).” - “Any observed changes or abnormal findings in the patient’s condition...must be reported to the qualified RN...who will assess the patient.” - “Document all findings in the patient’s medical record.” Review of policy and procedure #45284 titled, “Patient Assessment and Monitoring” Published 05/01/2023 Version 4 revealed: - “Record blood pressure (BP); recheck blood pressures after a drop...Report to the nurse any Systolic blood pressures greater than 180...Diastolic blood pressures greater than 100...” - “Document findings and interventions in the medical record.” - Lung sounds, Edema, Heart sounds: “The RN will assess/re-assess post treatment as indicated.” Fluid Assessments: Review of Pt #7’s Treatment Sheets revealed: -On 12/30/2025, Pt #7’s pre treatment nursing assessment at 11:01 AM revealed “3+ bilateral leg edema (swelling due to excess fluid in tissues)” and “Rhonchi (low-pitched rattling or gurgling)” lung sounds.” Per review of the post treatment nursing assessment at 5:13 PM, there was no documentation of the RN assessing/evaluating these concerns post treatment. -On 12/30/2025, Pt #7’s treatment ended at 1:49 PM, and there was no documented evidence of a post nursing assessment until 5:13 PM; 3 hours and 24 minutes later. Review of Pt #8’s Treatment Sheets revealed the following: -On 01/20/2026, Pt #8’s Estimated Dry Weight (EDW) was 53.5 kg (kilograms) and the post-treatment weight was 55.6 kg (2.1 kg above the EDW). There was no documentation of nursing interventions and notifying the physician to address Pt #8’s post weight being >1 kg above the EDW. -On 01/17/2026, Pt #8’s EDW was 53.5 kg and the post-treatment weight was 54.7 kg (1.2 kg above the EDW). There was no documentation of nursing interventions and notifying the physician to address Pt #8’s post weight being >1 kg above the EDW. Review of Pt #10’s Treatment Sheets revealed: -On 01/21/2026, Pt #10’s EDW was 91.6 kg and the post-treatment weight was 94.0 kg (2.4 kg above the EDW). There was no documentation of nursing interventions and notifying the physician to address Pt #10’s post weight being >1 kg above the EDW. Blood Pressure Nursing Assessments: Review of Pt #9 Treatment orders revealed to “Call MD” for SBP (systolic blood pressure) >180,” and “Diastolic blood pressure parameters High: 100 low: 50...Call MD if patient is outside of parameters and symptomatic...” Review of Pt #9’s Treatment Sheets revealed: -On 01/19/2026, Pt #9’s Blood Pressure (BP) was 190/118 (parameters systolic <180; Diastolic <100) at 3:02 PM, 198/121 at 3:39 PM, 180/101 at 4:03 PM, and 172/120 at 5:01 PM; there was no documentation of a nursing assessment addressing the BP being out of parameters as per policy. -On 01/19/2026, Pt #9’s BP dropped from 172/120 at 5:01 PM to 135/87 at 5:23 PM (37 point systolic drop) and there was no documentation of a nursing assessement. -On 01/21/2026, Pt #9’s BP was 197/115 at 5:35 PM; there was no documentation of a nursing assessment addressing the BP being out of parameters as per policy. Review of Pt #10’s Treatment orders revealed, “Diastolic blood pressure (DBP) parameters High: 100 low: 50...Call MD if patient is outside of parameters and symptomatic...” Review of Pt #10’s Treatment Sheets revealed: -On 01/19/2026, Pt #10’s DBP was 116 at 3:42 PM, 108 at 6:06 PM, and 121 at 7:26 PM. There was no documented evidence of a nursing assessment addressing the DBP being out of parameters as per policy. -On 01/21/2026, Pt #10’s DBP was 116 at 4:00 PM and 110 at 5:05 PM. There was no documented evidence of a nursing assessment addressing the DBP being out of parameters as per policy. During interview with Clinic Manager A on 01/23/2026 beginning at 1:00 PM, Manager A stated that nursing assessments and monitoring for blood pressure and fluid management should be completed and documented as per policy. Manager A stated that a nursing assessment should be performed when a patient’s systolic blood pressure drops more than 30 points between checks.”

“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: 29972 Based on record review and interview staff failed to recognize and address shortened treatments as per policy to ensure adequate dialysis in 1 of 5 in-center hemodialysis medical records reviewed (Patient (Pt) #10), in a total sample of 10 medical records reviewed. Findings Include: Review of policy and procedure #45263 titled, “Early Termination...” Version 3 published 11/07/2022 revealed: - “Patient requesting early termination of a treatment...will be referred to the supervising registered nurse.” - “The registered nurse (RN) will evaluate the patient and discuss with the patient their reason for requesting to terminate their treatment earlier than prescribed.” - “The RN who evaluates the patient must document the rationale for early termination and reinforce the consequences of not receiving the entire prescribed treatment.” - “The RN is responsible to notify the physician, and document on the “AMA” , or Against Medical Advice form.” Review of Pt #10’s Treatment Sheets revealed the following: -On 01/14/2026, Pt #10’s dialysis treatment time was ordered for 4 hours and 15 minutes. Treatment started at 6:55 AM and ended at 10:38 AM, 32 minutes short. There was no documentation of an AMA form, nursing interventions, and physician notification completed as per policy. -On 01/21/2026, Pt #10’s dialysis treatment time was ordered for 4 hours and 15 minutes. Treatment started at 3:42 PM and ended at 6:54 PM, 63 minutes short. There was no documentation of an AMA form, nursing interventions, and physician notification completed as per policy. During interview with Clinic Manager A on 01/23/2026 at 11:15 AM, Manager A stated that there are no AMA forms completed for Pt #10 on 01/14/2026 and 01/21/2026. Manager A stated that staff should complete an AMA form and document interventions and physician notification as per policy.”

“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: 29972 Based on record review, observation, and interview staff failed to perform skin antisepsis as per policy prior to initiating treatment using an Arteriovenous Fistula (AVF) in 3 of 3 patients observed (Patient (Pt) #1, #2, #3), and failed to evaluate the AVF before cannulation as per policy in 2 of 3 patients observed (Pt #1, #3), in a total sample of 5 observations of patients using an AVF. Findings Include: Review of policy and procedure #45178 titled, “Access Assessment and Cannulation” Version 5 published 05-05-2025, revealed the following: - “Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session.” - “Assessment of Vascular Access...Listen: Bruit...auscultate vascular accesses should listen with a stethoscope to the entire length of the access for changes in the sound of the bruit--a normal low-pitched bruit should be present...” - “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...” On 01/21/2026 beginning at 9:27 AM, observed Patient Care Technician (PCT) D initiating Pt #1’s dialysis treatment using an AVF. PCT D scrubbed vascular access site #1 with an alcohol wipe for 18 seconds and site #2 for 22 seconds prior to cannulation; PCT D did not perform skin antisepsis for 30 seconds each site as per policy. PCT D did not check for the bruit prior to cannulation as per policy. On 01/21/2026 beginning at 11:21 AM, observed PCT E initiating Pt #2’s dialysis treatment using an AVF. PCT E scrubbed vascular access site #1 with an alcohol wipe for 5 seconds and site #2 for 6 seconds prior to cannulation; PCT E did not perform skin antisepsis for 30 seconds each site as per policy. On 01/21/2026 beginning at 11:25 AM, observed PCT F initiating Pt #3’s dialysis treatment using an AVF. PCT F scrubbed vascular access site #1 with an alcohol wipe for 7 seconds and site #2 for 12 seconds prior to cannulation; PCT F did not perform skin antisepsis for 30 seconds each site as per policy. PCT F did not check for the bruit prior to cannulation as per policy. During interview with Clinic Manager A on 01/23/2026 at 11:15 AM, Manager A stated that staff should apply alcohol antiseptic for 30 seconds each site as per policy. Manager A stated staff should check the bruit using a stethoscope prior to cannulation.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to ensure that quality data is tracked, trended, and analyzed to address issues with Fluid Management and Hospitalizations in 3 of 3 Quality Assessment and Performance Improvement (QAPI) programs reviewed (In-Center Hemodialysis, home Peritoneal dialysis, home Hemodialysis), in a total of 3 QAPI programs reviewed. Findings include: Review of policy and procedure titled, “Quality Assessment and Performance Improvement Program” Published 11/04/2024 Version 6, revealed the following: -The dialysis facility must develop, implement, maintain, and evaluate an effective, date-driven QAPI (Quality Assessment Performance Improvement) with participation by the professional members of the interdisciplinary team (IDT). -QAPI Committee will monitor data/information; prioritize areas for improvement; determine root causes; develop, implement, evaluate, and revise action plans that result in sustainable improvements in patient care. -Performing a Root Cause Analysis on the identified opportunities to include, identification of commonalities, circumstances, conditions or barriers that are impacting quality improvement and facility indicators. -Documentation of meeting minutes should include...meeting checklist for monthly topics and discussion of meeting. Fluid Management: Review of the Fluid Management QAPI dashboard for October 2025, November 2025, and December 2026 data revealed there was no documented evidence of the facility tracking and trending Fluid indicators for home Peritoneal dialysis and home Hemodialysis. Review of the Meeting Minutes Report for October 2025, November 2025, and December 2025 meetings, revealed there was no documented evidence that staff discussed Fluid Management quality indicators in QAPI meetings for home Peritoneal dialysis and home Hemodialysis. Hospitalizations: Review of Hospitalization tracking in the QAPI dashboard revealed: -September 2025: 3 Fluid Overload, 2 Infection related, 3 Cardiac related. -October 2025: 3 Fluid Overload, 5 Infection related, 3 Cardiac related. -November 2025: 2 Fluid Overload, 5 Infection related, 3 Cardiac related Review of the Meeting Minutes Report for October 2025, November 2025, and December 2025 meetings, revealed there was no documented evidence that staff trended and analyzed hospitalization in QAPI for In-Center Hemodialysis, home Peritoneal dialysis, and home Hemodialysis. Per interview with Clinic Manager A and Clinic Manager B on 01/23/2026 beginning at 1:45 PM, there is no documented evidence of staff tracking, trending, and analyzing Fluid indicators for home Peritoneal and home Hemodialysis and trending and analyzing Hospitalizations in QAPI for all modality types.”