Fresenius Medical Care Midwest Lakeshore

“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: 29972 Based on observation, interview, and record review the staff failed to wear personal protective equipment (PPE) appropriately when initiating dialysis treatment in 1 of 12 patient care observations (Patient (Pt) #13), in a total sample of 12 patient observations of care. Findings Include: Review of policy and procedure #47663 titled, “Personal Protective Equipment” version 6 Published 11/06/2023 revealed; - “Personal protective equipment including a full face-shield or mask and protective eyewear with full side shield, fluid-resistant gowns and gloves, must be worn to protect employees from blood or other potentially infectious materials.” On 11/13/2024 beginning at 12:08 PM, observed Registered Nurse (RN) G initiating Pt #13’s dialysis treatment using a Central Venous Catheter (CVC). RN G’s wrist watch and wrist band were not covered by RN G’s lab coat sleeve, exposing the watch and wrist band to potential blood splatter during Pt #13’s dialysis treatment initiation. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing observations, CM A stated that RN G’s lab coat sleeves should have covered her watch and wrist band while initiating dialysis treatment.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 29972 Based on observations, interview, and record review staff failed to immediately dispose of potentially infectious waste in 1 of 12 patient care observations (Patient (Pt) #12), in a total sample of 12 patient observations of care. Findings Include: Review of policy and procedure #45651 titled, “Initiation of Treatment Using a Central Venous Catheter (CVC)...” Version 8 published 05/06/2024 revealed to “...6. Attach a sterile empty 10 mL (milliliter) syringe...7. Remove heparin (or other locking agent) by unclamping arterial catheter limb and gently aspirating 5 mL fluid from the catheter lumen, then re-clamp. Repeat with venous catheter limb...9. Discard the blood-filled syringe from the arterial limb into the sharps container...” On 11/13/2024 beginning at 10:43 AM observed Patient Care Technician (PCT) E initiating Pt #12’s dialysis treatment using a CVC. PCT E aspirated 5 mL of fluid from the arterial limb and venous limb and placed both blood filled syringes on the tray table connected to the dialysis chair while continuing to initiate treatment. PCT E did not immediately discard the blood-filled syringes into the sharps container as per policy. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing observations, DO C stated that staff should immediately discard the blood filled syringe into the sharps container and not place on the tray table.”

“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) #1), in a total sample of 2 observations of station cleaning; and failed to clean and disinfect the hemostat clamps as per policy in 1 of 1 observations of handling hemostat clamps after patient treatment (Patient (Pt) #17), in a total of 12 patient care observations. Findings Include: Review of policy and procedure (no number) titled, “Cleaning and Disinfecting the Dialysis Station” version 11 published 11/02/2020 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 a IV (intravenous) pole, BP (blood pressure) cuff and hand sanitizer/holder...” - “Place used...plastic hemostat clamps in a labeled opaque plastic container filled with a 1:100 bleach solution...Make sure the items are completely submerged, unclamped, and in open position when placed in the solution...Allow items to soak in the solution at least 10 minutes...” On 11/14/2024 beginning at 8:30 AM observed Patient Care Technician (PCT) E place 2 used hemostat clamps into an empty bleach container after Pt #17’s dialysis treatment. The bleach container did not contain a bleach solution as per policy. During interview with Registered Nurse (RN) F on 11/14/2024 beginning at 8:40 AM, RN F stated that staff do not typically make the bleach solution for the hemostat clamps until after the first patient change over, so clamps are placed into the empty bleach container until the bleach solution is made. During interview with Clinic Manager (CM) A on 11/14/2024 beginning at 8:52 AM, CM A stated that staff should be making the bleach solution first thing in the morning and clamps should be placed in the bleach solution to soak after use. On 11/13/2024 beginning at 10:00 AM, observed RN D cleaning and disinfecting St #1; RN D did not clean the following: - Outsides of the dialysis chair under the tray tables - Fold down tray tables to clean between the arm rest and tray table - Bottle of hand sanitizer/holder - Oxygen Concentrator stored at the station During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing observations, CM A stated that staff should be cleaning the identified equipment at the dialysis station between patient treatments.”

“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 3 patients observed with a CVC (Patient (Pt) #12) in a total sample of 3 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 the following: -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 for 30 seconds...” On 11/13/2024 beginning at 10:25 AM, observed Patient Care Technician (PCT) E performing Pt #12’s CVC exit site care. PCT E cleansed the skin surrounding the CVC exit site with Chloraprep for 17 seconds and not 30 seconds as per policy. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing observations, CM A confirmed that Chloraprep antiseptic should be applied for 30 seconds as per policy.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 29972 Based on observation, interview, and record review staff failed to ensure that all patient’s vascular access sites are visible during dialysis treatment in 2 of 12 patients observed (Patient (Pt) #8, 9), in a total sample of 12 patients observed. Findings Include: Review of policy and procedure #47266 titled, “Patient Monitoring During Hemodialysis Treatment” Version 2 published 02/07/2022 revealed to “Monitor patient’s access with each check to ensure the access is visible and that there is no unusual bleeding or infiltration. Patient’s should be instructed to leave access sites uncovered so that they are readily visible at all times.” On 11/13/2024 between 9:30 AM and 9:45 AM, observed Pt #8’s vascular access site covered with a blanket during dialysis treatment, not allowing for visibility of Pt #8’s vascular access. On 11/13/2024 between 11:35 AM and 1:25 PM, observed Pt #9’s vascular access site covered with a blanket during dialysis treatment, not allowing for visibility of Pt #9’s vascular access. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing observations, CM A and DO C stated that vascular access sites should be uncovered at all times during dialysis treatment.”

“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 evaluations address patient’s fluid management needs in 2 of 7 records reviewed (Patients (Pt) #2 and 5), in a total sample of 7 medical records reviewed. Findings include: Review of policy titled, “Nursing Supervision and Delegation” Published 11/06/2023 Version 6 revealed the following: - “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.” - “Document all findings in the patient’s medical record.” Review of Pt #2’s treatment sheets revealed the following: - On 11/04/2024: Pt #2’s Estimated Dry Weight (EDW) was 125 kg (kilograms) and the post-treatment weight was 128.3 kg (3.3 kg above the EDW). There was no documentation of the nurse notifying the Provider to address Pt #2’s post weight being >1 kg above the EDW. - On 11/06/2024: Pt #2’s EDW was 125 kg and the post-treatment weight was 127.6 kg (2.6 kg above the EDW). There was no documentation of nursing interventions including notifying the provider to address Pt #2’s post weight being >1 kg above the EDW. Review of Pt #5’s treatment sheets revealed the following: - On 11/07/2024: Pt #5’s Estimated Dry Weight (EDW) was 115.0 kg (kilograms) and the post-treatment weight was 119.5 kg (4.5 kg above the EDW). There was no documentation of nursing interventions including notifying the provider to address Pt #5’s post weight being >1 kg above the EDW. - On 11/09/2024: Pt #5’s EDW was 115.0 kg and the post-treatment weight was 120.1 kg (5.1 kg above the EDW). There was no documentation of nursing interventions including notifying the Provider to address Pt #5’s post weight being >1 kg above the EDW. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing medical record findings, CM A confirmed the findings and stated that the nurse should notify the provider and document the nursing interventions when patients have a post weight 1.0 kg greater than their ordered EDW.”

“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 follow prescribed blood flow rates for 3 of 7 medical records reviewed (Patients #1, 2, 4), in a total sample of 7 medical records reviewed. Findings include: Review of policy and procedure #47334 titled, “Unable to Achieve Prescribed Blood Flow Rate” version 3 published 11/01/2021 revealed: - “Achieving prescribed BFR (Blood Flow Rate) is a critical parameter in achieving adequate treatment Kt/V (adequacy).” - “Notify physician/extender if unable to achieve prescribed blood flow rate.” - “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.” A review of Pt #1’s medical record revealed a physician order for BFR of 400. Review of Pt #1’s dialysis treatment sheets revealed the following: -On 11/07/2024 the BFR was set at 350 during dialysis treatment. There was no documentation in the medical record of the reason the BFR was not set at the ordered rate and notification to the provider. A review of Pt #2’s medical record revealed a physician order for BFR of 450. Review of Pt #2’s dialysis treatment sheets revealed the following: -On 11/08/2024 the BFR was set at 400 during dialysis treatment. There was no documentation in the medical record of the reason the BFR was not set at the ordered rate and notification to the provider. A review of Pt #4’s medical record revealed a physician order for BFR 300-600 as long as AP (arterial pressure) is not greater than -250. Review of Pt #4’s dialysis treatment sheets revealed the following: -On 10/30/2024 at 6:04 PM, BFR was set at 500 with an AP of -262; at 8:01 PM BFR set at 500 with an AP of -268. The BFR was not adjusted to ensure AP was not greater than -250 as per physician order. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing medical record findings, CM A confirmed the findings and stated that if BFR cannot not be maintained as per physician orders, staff must document the reason BFR was not met, document interventions completed, and notify the provider.”

“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 when when using a Arteriovenous Fistula/Graft (AVF/G) in 1 of 2 observations of staff initiating treatment using an AVF/G (Patient (Pt) #14), in a total sample of 4 observations of patients using a AVF/G. Findings Include: Review of policy and procedure #45178 titled, “Access Assessment and Cannulation” version 4 published 05-06-2024, revealed the following: - “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...” - “Perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection...” On 11/13/2024 beginning at 12:53 PM, observed Patient Care Technician (PCT) H initiating Pt 14’s dialysis treatment using an AVF/G. PCT H cleansed vascular access site #1 with an alcohol wipe for 15 seconds and cleansed site #2 for 19 seconds; PCT H did not perform skin antisepsis for 30 seconds each site as per policy. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing observations, CM A stated that staff should apply alcohol antiseptic for 30 seconds each site as per policy.”

“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: 29972 Based on observation, interview, and record review the facility failed to ensure nursing staff safely administer medications as per policy in 1 of 2 medication administration observations (Patient (Pt) #10); failed to ensure nursing staff verify medications before giving to ensure the correct medications is administered in 2 of 3 medication administration observations (Pt #10, 11), in a total sample of 2 medication administration observations; and failed to ensure all medications are secured from unauthorized access as per policy in 1 of 1 emergency medications observed (Crash cart), in a total sample of 1 set of emergency medications observed. Findings Include: Review of policy and procedure titled, “Special Considerations: Venofer” Version 3 published 07-01-2024 revealed, “Venofer (iron) may be administered undiluted as a slow intravenous injection over 2 to 5 minutes.” Review of policy and procedure #46865 titled, “Emergency Medications, Equipment, and Supplies” Version 6 published 05/01/2023 revealed, “The emergency cart must be locked when not in use...” Review of policy and procedure #47488 titled, “Medication Preparation and Administration” Version 9 published 02/06/2023 revealed, “Prior to administration of the medication: ...Verify there is a physician order.” On 11/13/2024 beginning at 12:00 PM, observed Registered Nurse (RN) D administering intravenous (IV) Venofer to Pt #10 during dialysis treatment. RN D administered the Venofer over 1 minute and 10 seconds, per policy Venofer should be administered over 2 to 5 minutes. RN D did not verify the physician order prior to administering the medications to Pt #10 as per policy. On 11/14/2024 beginning at 8:30 AM, observed RN F administering IV medications (Hectoral and Iron) to Pt #11 during dialysis treatment. RN F did not verify the physician order prior to administering the medications to Pt #11 as per policy. On 11/13/2024 beginning at 1:45 PM, observed the Crash Cart (emergency cart) containing emergency medications including; Sodium Bicarbonate, Narcan, Epinephrine, Solumedrol, Calcium Chloride, Heparin, and Benadryl. The Crash cart was secured with a plastic pull tab. Per interview with RN D on 11/13/2024 at 11:50 PM, RN D stated that housekeeping staff clean the dialysis facility at night after staff leave the building. RN D stated the Crash cart is not locked up at night and the medications remain in the Crash cart. This allows for potential unauthorized access to medications. During interview with Clinical Manager (CM) A, Director of Operations (DO) C, and Area Team Lead (ATL) B on 11/14/2024 beginning at 4:25 PM, while discussing observations, CM A and DO C stated that nursing staff should verify the physician orders before administering medications. DO C stated that Venofer should be administered as per policy.”