Fresenius Medical Care - Manitowoc

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 43037 Based on observation, interview and record review, the facility staff failed to perform glove changes and/or hand hygiene when moving from “dirty” to “clean” tasks while providing cares for 3 of 12 patients (Patients # 3, 9 & 11) in a sample of 16 observations of patient care. Findings include: A review of facility policy 47664 “Hand Hygiene” Version 8 revealed, “...Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water...Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications...After contact with inanimate objects near the patient...” A review of facility policy 47488 “Medication Preparation and Administration” Version 9 revealed, “...The following steps must be taken to ensure infection control: Perform hand hygiene prior to accessing supplies, handling vials and IV solutions and preparing or administering medications...” During an observation on 2/21/2024 at 10:44 AM Certified Clinical Hemodialysis Technician (CCHT) F was preparing to begin treatment on Patient #9. CCHT F used the keyboard, handled blood tubing, handled Patient #9’s personal belongings, placed a blood pressure cuff on Patient #9 and assisted Patient #9 to stand for a blood pressure check all with gloved hands. PCT F then immediately moved to the chairside table and opened the CVC (central venous catheter) kit, removed the sterile syringes from their wrappers and opened other wrapped items in the kit without first removing “dirty” gloves, performing hand hygiene and putting on “clean” gloves. During an observation on 2/21/2024 at 11:29 AM Registered Nurse (RN) I was preparing intravenous (IV) medications to administer to Patient #11. RN I prepared the medication without first performing hand hygiene then donned gloves without performing hand hygiene and then administered the medication to Patient #11. During an observation on 2/21/2024 at 11:37 AM RN I was preparing IV medications to administer to Patient #3. RN I prepared the medication without first performing hand hygiene then donned gloves without performing hand hygiene and then administered the medication to Patient #3. During an interview on 2/22/2024 at 9:42 AM, the observation findings were discussed with Area Team Lead A who agreed that hand hygiene and glove changes should have been performed per policy.”

“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: 47413 Based on record review, interview and observation, staff failed to recognize and discard expired supplies in 1 of 1 lab storage areas observed. Findings Include: A review of the facility’s policy titled, “Storage of Supplies” Version 2 published on 04/05/2021 revealed, “... Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date...” During an observation on 02/21/2024 at 8:52 AM, 15 vials of “Protocol Cary Blair Medication” (a test to detect enteric parasites) 15mL (milliliters) solution expired on 01/31/2022. Observation on 02/21/2024 at 8:52 AM revealed 4 “BBL CultureSwab Plus” aerobic and anaerobic collection systems expired on 03/21/2023. During an observation on 02/21/2024 at 8:55 AM, 1 of 2 “EZ Check Blood Leak Test Strips” expired on 09/30/2022. Observation on 02/21/2024 at 8:55 AM revealed 15 “Hema-screen Fecal Occult Blood Tests” expired on 02/28/2023. During an observation on 02/21/2024 at 8:59 AM, 7 boxes of 2 sets of blood culture lab tests expired on 07/19/2023, 07/22/2023, 10/07/2023, and 02/15/2024. During an interview on 02/21/2024 at 9:00 AM with Clinic Manager C, when asked about the expired supplies, Clinic Manager C stated, “Yes, those are expired and should have been discarded.””

“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: 29963 Based on record review, observation and interview, the facility staff failed to use the correct bleach solution to disinfect while cleaning up blood on the treatment floor and wheelchair to prevent possible cross contamination for 1 of 1 patient (Patient #10) whose access began to bleed after completion of the dialysis treatment in a total of 16 observations of patient care. Findings include: A review of the facility’s policy 47806 titled, “Cleaning and Disinfection the Dialysis Station,” last revised 09/05/2023 revealed, “Use 1:10 bleach solution to clean surface with visible blood.” During an observation on 02/21/2024 at 10:50 AM, Patient #10 was propelling own wheel chair through the treatment area when access on Patient #10’s left arm began to bleed out onto the floor. Clinic Manager C and Registered Nurse J were observed using 1:100 bleach solution to wipe up the blood on the floor and on Patient #10’s wheelchair. During an interview on 02/22/2023 at 9:43 AM, the observation findings were discussed with Area Team Lead A and Clinic Manager C. Area Team Lead A stated, “Blood should be cleaned up with 1:10 bleach concentration.””

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 43037 Based on observation, record review and interview the facility staff failed to perform independent pH (denotes acidity or basicity) testing of dialysate prior to treatment for 1 of 2 patients (Patient #9) in a total sample of 2 observations of the preparation of machines. Findings include: A review of facility policy 25912 “Checking Conductivity and pH of Final Dialysate” Version 9 revealed, “...The final dialysate conductivity and pH must be tested prior to each patient’s treatment...Note: If BlueStar software is enabled for independent conductivity and pH readings, an external meter is not requirement (sic) to measure pre-treatment conductivity and pH. This is only allowed on BlueStar machines with a bibag system...” During observation and concurrent interview with Registered Nurse (RN) I on 2/21/2024 at 8:35 AM, it was noted the dialysis machines were Fresenius 2008T machines and not BlueStar machines. RN I stated that the dialysis machines have been upgraded to include software that checks the conductivity of the dialysate and therefore does not require a measurement of conductivity to be taken pre-treatment, but the upgrade does not yet include the use of the bibag system. During an observation and concurrent interview with Certified Clinical Hemodialysis Technician (CCHT) F on 02/21/2024 at 9:20 AM, CCHT F was observed to prepare the machine for Patient #9’s dialysis. CCHT F did not perform a pH test pre-treatment. CCHT F stated that the machine upgrade also independently checks pH so that a pre-treatment measurement of pH is not required by staff. PCT F prepared the machine for Patient #9 and did not perform a pH test pre-treatment. During an interview on 2/22/2024 at 9:42 AM, the observation findings were discussed with Area Team Lead A who stated the pH must be checked on all machines pre-treatment because the machines have not been completely upgraded to BlueStar status and while the machines independently check the conductivity, they do not yet check the pH.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 29963 Based on observation and interview, staff failed to maintain a sanitary environment free from potential infection risk in 7 of 14 treatment and training chairs in a total of 3 areas observed. Findings Include: Observation on 02/21/2024 starting at 4:28 PM revealed the following findings: Treatment chair 1 had a crack in the right chair arm exposing the vinyl of the chair. Treatment chair 3 had a crack in the left chair arm and on the middle of the seat exposing the vinyl of the chair. Treatment chair 4 had a crack in the right chair arm and on the middle of the seat exposing the vinyl of the chair. Treatment chair 7 had a crack on the middle of the seat exposing the vinyl of the chair. Treatment chair 9 had a crack on the right chair arm and on the middle of the seat exposing the vinyl of the chair. Treatment chair 10 had a crack on the left chair arm exposing the vinyl of the chair. Training room chair 2 had a crack on the middle of the seat exposing the vinyl of the chair. During an interview on 02/22/2024 at 9:53 AM, when asked about the following observations, RN (Registered Nurse) Area Team Lead A stated, “Yes, we have those parts ordered for the chairs.” Clinic Manager C stated, “As soon as staff notice something like this, they should let us know so that we can order the parts and fix the problem.” 47413”

“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: 43037 Based on record review and interview the facility staff failed to ensure the administration of pre-treatment Heparin bolus was at least 3 to 5 minutes prior to the initiation of dialysis, per facility policy, in 1 of 3 in-center hemodialysis patients (Patient #1) with current active orders for Heparin boluses in a total sample of 5 medical records reviewed. Findings include: A review of facility policy “Heparinization” Version 4 revealed, “...Heparin (anticoagulant medication) must be given at least 3-5 minutes prior to dialysis. This allows time for full anticoagulation at the start of treatment...” A review of Patient #1’s medical record revealed a physician order for Heparin 2,500 units IV (intravenous) bolus to be given every treatment. Treatment sheet dated 2/12/2024 revealed Heparin 2,500 units given at 10:51 AM and treatment started at 10:53 AM (2 minutes after Heparin bolus given). Treatment sheet dated 2/14/2024 revealed Heparin 2,500 units given at 10:52 AM and treatment started at 10:53 (1 minute after Heparin given). During an interview on 2/22/2024 at 9:42 AM the medical record review findings were discussed with and confirmed by Clinic Manager C who stated, “They need to wait 3 to 5 minutes after giving the Heparin before starting treatment.””

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 29963 43037 Based on record review and interview facility staff failed to ensure patients had measurable updated goals in their plans of care in 3 of 5 (Patients #1, 3, 5) medical records in a sample of 5 medical records reviewed. Findings include: A review of facility policy 45238 “Comprehensive Interdisciplinary Assessment and Plan of Care” Version 6 revealed, “...The Plan of Care must include measurable and expected outcomes and an estimated timetable to achieve these outcomes...” A review of Patient #1’s medical record revealed the “Plan of Care” areas of focus, Body Weight had a “Goal Due” date of 10/31/2023, and Hyper/Hypokalemia, Treatment Adherence, Advance Directives/End of Life Issues, Emotional/Mental Health, Achieve and Maintain Optimum Level of Independent Functioning, Coping/Adjusting to Dialysis Issues, Place Patient on Transplant List as Indicated by the Patient’s Physician, and Albumin Management all had “Goal Due” dates of 11/30/2023. All the above goals were listed as “open and in progress”. Goals were past due and the goal dates were not updated. A review of Patient #3’s medical record revealed the “Plan of Care” areas of focus, Dialysis Access had a “Goal Due” date of 01/01/2024, Diabetes Management had a “Goal Due” date of 07/31/2023, Anemia Management had a “Goal Due” of 01/12/2023, Mineral Metabolism/Bone Disease had a “Goal Due” date of 12/31/2023, Body Weight had a “Goal Due” date of 08/31/2023, and Albumin Management had a “Goal Due” date of 10/31/2023. All the above goals were listed as “open and in progress”. Goals were past due and the goal dates were not updated. A review of Patient #5’s medical record revealed the “Plan of Care” areas of focus, Transplant Status had a “Goal Due” date of 06/30/2023, Body weight had a “Goal Due” date of 04/30/2023, Mineral Metabolism/Bone Disease had a “Goal Due” date of 06/30/2023, Albumin Management had a “Goal Due” date of 06/23/2023. All the above goals were listed as “open and in progress”. Goals were past due and the goal dates were not updated. During an interview on 2/22/2024 at 9:00 AM the medical record review findings were discussed with and confirmed by Clinic Manager C who when asked if plan of care due dates should be updated to remain current to patient needs stated, “Yes.” listed as “open and in progress.” Goals were past due and no updated dates were”

“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: 43037 Based on record review and interview, the facility staff failed to ensure intradialytic blood pressure monitoring was completed per facility policy in 1 of 4 Patients (Patient #1) in-center medical records in a total universe of 5 medical records reviewed. Findings include: A review of facility policy 45284 “Patient Assessment and Monitoring” Version 4 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...” A review of Patient #1’s medical record revealed treatment sheet dated 2/9/2024 at 10:52 AM a blood pressure of 144/79 and a pulse of 73 was documented. At 11:02 AM a blood pressure of 153/88 was documented. No pulse was documented at this time. At 11:45 AM a blood pressure of 114/54 and a pulse of 72 was documented. Patient #1’s pulse was not recorded for 53 minutes (8 minutes more than maximum time limit per policy). Treatment sheet dated 2/12/2024 at 1:03 PM a blood pressure of 115/69 and a pulse of 81 was documented. At 2:04 PM a blood pressure of 140/69 and a pulse of 86 was documented (61 minutes after previous blood pressure and pulse, 16 minutes more than maximum time limit per policy). During an interview on 2/22/2024 at 9:00 AM observation findings were discussed with Clinic Manager C who stated, “Blood pressures and pulses should be taken every 30 minutes, but they should not exceed 45 minutes.””

“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: 47413 Based on record review, observation and interview, the facility staff failed to perform skin antisepsis prior to cannulation per policy for 2 of 2 patients (Patients # 11, 12) observed for initiation of dialysis with an AV Fistula/Graft in a total of 16 observations of patient care. Findings Include: A review of the facility’s policy #45178, titled, “Access Assessment and Cannulation” last reviewed 07/05/2022 revealed, “1. Disinfect cannulation site as follows ... 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.” During an observation on 02/21/2024 at 10:22 AM, PCT (Patient Care Technician) E used alcohol to cleanse Patient #11’s arm access sites prior to cannulation for a total of 25 seconds, 5 seconds less than policy. During an observation on 02/21/2024 at 11:25 AM, CCHT (Certified Clinical Hemodialysis Technician) F used alcohol to cleanse Patient #12’s arm access sites prior to cannulation for a total of 10 seconds, 20 seconds less than policy. During an interview on 02/22/2024 at 9:41 AM with RN (Registered Nurse) Area Team Lead A, when asked about the following observations, RN Area Team Lead A stated, “They should be cleaning the access sites for 30 seconds with alcohol.””

“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: 29963 Based on record review and interview, the facility staff failed to ensure data is being collected, analyzed, and trended to identify potential problems with blood pressure monitoring and fluid management for 1 of 1 Home Peritoneal Dialysis Training and Support program in the monthly quality meetings for a total of 2 dialysis services. Findings include: A review of the facility’s policy #25799 titled, “Quality Assessment and Performance Improvement Program (QAPI),” effective date, 05/02/2022 revealed, “The Quality Assessment and Performance Improvement (QAPI) Program encompasses all aspects of patient care, including in-center...home peritoneal dialysis and self-care, as well as support services to provide that care...The QAPI Program is designed and implemented to objectively, systematically, and comprehensively monitor, evaluate, and improve the quality and safety of patient care and services...to achieve measurable improvement of health outcomes...ensure the required topics per the Conditions for Coverage are reviewed on a montly, quarterly, and annually cadence.” A review of the facility’s Quality Assessment and Performance Improvement Program with Clinical Manager C, including data from November 2023 through January 2024 on 02/22/2024 at 11:00 AM, revealed the Home Peritoneal Dialysis quality program dashboard does not include documentation related to data for fluid and blood pressure management for home peritoneal dialysis patients. A review of the QAPI meeting minutes for Peritoneal Dialysis dated 12/2023 revealed, “BP/Fluid Dashboard: Reviewed with MD”. Meeting minutes from 01/2024 revealed, “BP/Fluid Dashboard: Dashboard reviewed with MD (Medical Doctor”. There was no evidence of tracking and trending of the data. During an interview with Clinical Manager C on 02/22/2024 at 11:20 AM, A stated, “The PD Home Program does not have data regarding fluid and blood pressure management in the quality meetings dashboard..””

“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: 43037 Based on record review and interview the facility staff failed to ensure that a comprehensive Registered Nurse assessment was completed prior to initiation of the first treatment at the facility in 1 of 1 newly admitted patient (Patient #2) reviewed in a total sample of 5 medical records reviewed. Findings include: A review of facility policy 45625 “Nursing Supervision and Delegation” Version 6 revealed, “...The following tasks that may not be delegated: Assessment of patient prior to treatment initiation for patients new to dialysis and receiving their first ever outpatient dialysis treatment...” A review of facility policy 45283 “Comprehensive Interdisciplinary Assessment and Plan of Care” Version 6 revealed, “...A registered nurse must perform an assessment on patients new to dialysis before initiation of their first treatment to determine immediate needs...” A review of Patient #2’s medical record revealed Patient #2 was admitted for their first dialysis treatment on 1/31/2024. The first dialysis treatment was started on 1/31/2024 at 12:47 PM. Patient #2’s “Initial Assessment” was completed on 1/31/2024 at 1:07 PM (20 minutes after initiation of first dialysis treatment). During an interview on 2/22/2024 at 9:42 AM, the observation findings were discussed with Area Team Lead A who when asked if the initial assessment should have been completed prior to initiating treatment responded, “Yes.””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 29963 47413 Based on record review and interview, the facility staff failed to ensure nursing staff were labeling their post dialysis treatment assessment as “late entry,” per facility policy for 2 of 5 patients (Patients #3, 4) in a total universe of 5 medical records reviewed. Findings Include: A review of the facility policy #46940 titled, “Medical Record Documentation Standards” Version 4 last published on 02/05/2024 revealed, “... When a pertinent entry was missed or not written in a timely manner, a late entry shall be used to record the information in the medical record. 1. Identify the new entry as a ‘late entry.’ 2. Enter the current full date and time. 3. Identify or refer to the date and incident for which the late entry is written...” A review of the facility policy #45265 titled, “Nursing Supervision and Delegation” Version 6 last published on 11/06/2023 revealed, “... Daily Treatment: Prior to discharge the RN (Registered Nurse) must review the treatment record to: Confirm patient is stable for discharge... Document all findings in the patient’s medical record...” A review of Patient #3’s medical record revealed a treatment sheet dated 02/07/2024, treatment was documented as completed at 2:08 PM and the post nursing assessment was documented at 2:44 PM. No “late entry” documented. The treatment sheet dated 02/12/2024 revealed Patient #3’s treatment was documented as completed at 2:18 PM and the post nursing assessment was documented at 2:39 PM. No “late entry” documented. The treatment sheet dated 02/14/2024 revealed Patient #3’s treatment was documented as completed at 1:46 PM and the post nursing assessment was documented at 2:27 PM. No “late entry” documented. The treatment sheet dated 02/19/2024 revealed Patient #3’s treatment was documented as completed on 2:33 PM and the post nursing assessment was documented at 2:44 PM. No “late entry” documented. A review of Patient #4’s medical record revealed on the treatment sheet dated 02/07/2024, Patient # 4’s treatment was documented as completed at 2:08 PM and the post nursing assessment was documented at 2:48 PM. No “late entry” documented. The treatment sheet dated 02/09/2024 revealed Patient #4’s treatment was documented as completed at 2:02 PM and the post nursing assessment was documented at 2:46 PM. No “late entry” documented. The treatment sheet dated 02/12/2024 revealed Patient #4’s treatment was documented as completed at 2:01 PM and the post nursing assessment was documented as 2:59 PM. No “late entry” documented. The treatment sheet dated 02/14/2024 revealed Patient #4’s treatment was documented as completed at 2:25 PM and the post nursing assessment was documented at 3:04 PM. No “late entry” documented. The treatment sheet dated 02/19/2024 revealed Patient #4’s treatment was documented as completed at 2:45 PM and the post nursing assessment was documented at 3:26 PM. No “late entry” documented. During an interview on 02/22/2024 at 12:34 PM, the medical record review findings were discussed with and confirmed by RN Area Team Lead A who stated, “If the entry is entered any time after the patient is discharged, they should be documenting their assessments as ‘late entry.’””