Fresenius Medical Care Swan Lake Dialysis Center

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 41879 Based on observations, staff interview and review of the facility policy, “Hand Hygiene”, the dialysis facility staff failed to ensure patients performed hand hygiene after possible exposure to blood or body fluids to prevent cross contamination for 1 of 3 Patient Care Technician (PCT) observed. ( PCT #3). The findings include: On 6/18/24 at 10:50 AM observations are made in the treatment area of the facility. The patient at Station # 8 has a glove on his left hand and is holding the Central Venous Catheter (CVC) bloody lines post dialysis treatment with his left gloved hand. The patient at Station #8 then doffs the glove to the left hand after the nurse takes the CVC lines from the patient and walks over to the scale area touching the scales digital surface with his left hand. PCT #3 brought hand sanitizer to the patient after he touched the scale surface but did not clean the scale surfaces where the patient touched. During an interview on 6/18/24 at 10:55 AM, Patient Care Technician (PCT) #3 verified the findings. Facility policy,entitled “Hand Hygiene,” reads, “Hand Hygiene Patients: Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as when self-cannulating or holding access sites post treatment to achieve hemostasis. To help prevent cross contamination to their family members or other patients, hand hygiene must be performed..”.”

“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: 41879 Based on observations, staff interviews and review of the facility policy, “Hand Hygiene” the dialysis facility staff failed to perform hand hygiene between patients to prevent cross contamination between patients for 1 of 3 Registered Nurses observed. (RN #2) The findings include: On 6/18/24 at 11:00 AM observations are conducted in the treatment area of the facility of RN #2 providing care to a patient at Station #6. RN #2 has gloves on and touches the patient’s blanket and checks the patient’s right Central Venous Catheter (CVC) groin site. RN #2 then typed information in the computer screen at Station #6, walked to station #7 and touched the computer screen and then checked the patients fistula site. RN #2 then doffs the gloves and performs hand hygiene. RN #2 did not change gloves and/or perform hand hygiene between patient care at Stations #6 and #7. During an interview on 6/19/24 at 2:00 PM, RN #2 verified the findings. Facility policy, entitled, “Hand Hygiene,” reads, “Decontamination using alcohol-based hand rub or by washing hands with antimicrobial soap and water must be done before and after direct contact with patients, entering and leaving the treatment area, before performing invasive procedures such as vascular access cannulation or administration or parenteral medications immediately after removing gloves, after contact with body fluids or excretions, mucous membranes. non-intact skin, and wound dressings hands visibly soiled, and after contact with inanimate objects near the patient”.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 41879 Based on observation, staff interview and review of facility policy, “Medication Preparation and Administration,” the dialysis facility staff failed to follow standard infection control practices while administering parenteral medication for 1 of 3 Registered Nurses (RN) observed. (RN #2). The findings include: On 6/19/2024 at 9:55 AM observations are conducted in the treatment area of the facility. RN #2 is observed placing a clear fluid filled syringe on top of the dialysis machine at Station #1. The patient at Station #1 just had a fistula accessed by the Patient Care Technician (PCT). RN # 2 does hand hygiene and dons gloves. RN #2 takes the syringe with the liquid from on top of the dialysis machine. RN #2 administers the clear liquid via the fistula line with no disinfection of the vial septum with alcohol before administering the liquid in the syringe. During an interview on 6/19/2024 at 2 PM, RN # 2 verified the clear liquid in the syringe was heparin and he/she should not have placed the syringe on top of a dirty dialysis machine and he/she did not wipe the septum with alcohol before administering heparin” Facility policy, entitled “Medication Preparation and Administration,” reads, “Filled syringes do not have to be labeled if drawn up and administered immediately. These unlabeled, filled syringes must not be placed down at any time...”Disinfect Intravenous (IV) ports prior to accessing, using friction and 70 % alcohol, idophor or chlohexidine/alcohol agent. Cleanse the diaphragm with a new alcohol wipe each time an IV port is accessed. Allow to dry prior to accessing...”.”

“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: 36779 Based on observation, staff interview and review of the facility policy “Central Venous Catheter (CVC) Dressing Change,” the dialysis facility failed to ensure infection prevention measures were practiced with CVC dressing changes for 2 of 3 Registered Nurses (RN’s) observed. (CN and RN #1). Findings include: Observation on 6/17/24 at 12:07 PM during CVC dressing change the Charge Nurse (CN) was observed changing the CVC dressing to a patient at station #5 and the patient did not have his/her nose covered with a mask and did not have his/her head turned away from the CVC site during CVC site care. Observation on 6/17/24 at 12:42 PM, the CN was observed changing the CVC dressing to a patient at station #4 and the patient did not have her/his nose covered and did not have her/his head turned away from the CVC site during CVC site care. Observation on 6/17/24 at 1:04 PM, the CN was observed changing the CVC dressing to a patient at station #19 and the patient did not have his/her nose covered with a mask and did not have his/her head turned away from the CVC site during CVC site care. During an interview on 6/17/24 at 1:20 PM, the CN confirmed the findings. Facility policy, entitled “Central Venous Catheter (CVC) Dressing Change” reads, “The patient and Inpatient Services Staff must wear mask for all procedures that requiring accessing the catheter to help prevent contamination by airborne nasal bacteria”. 41879 On 6/17/2024 at 11:22 AM observations are conducted in the treatment area of the dialysis facility. Registered Nurse (RN) #1 is performing catheter care dressing changes at station #17. RN #1 removes the old CVC dressing from the patient’s chest, continues with CVC care, begins to disinfect and flush the CVC lines with no glove removal and/or hand hygiene observed after the old dressing is removed and discarded. During an interview on 6/18/24 at 2:15 PM, RN #1 verified the findings.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 41879 Based on record review, staff interviews and review of the facility policy, “Microbial Monitoring of Central Water and Concentrate mixing and Delivery Systems,” the dialysis facility failed to obtain cultures prior to disinfection of the Continuous Water Pressure (CWP) system. Findings include: On 4/17/2024 at 2:00 PM the cultures for the CWP system are reviewed. Review of the weekly CWP disinfection log for February revealed the CWP was disinfected on 2/13/2024 with the monthly cultures for the CWP collected on 2/14/2024, one day after the disinfection. Further review of the CWP disinfection log revealed the CWP was disinfected on 4/09/2024 with the monthly cultures for the CWP collected on 4/10/2024, one day after the disinfection. During an interview on 6/18/24 at 9:15 AM, Biomedical Technician (BMT #1) verified the findings. Facility policy, entitled “Microbiological Monitoring of Concentrate Mixing and Delivery Systems,” reads, “Scheduled sampling, samples will be collected prior to disinfection and within 96 hours of disinfection...”.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 41879 Based on record review, staff interviews and review of facility policy, “Comprehensive Interdisciplinary Assessment and Plan of Care”, the dialysis facility failed to ensure 1 of 1 new patient charts reviewed had a Registered Nurse (RN) perform an assessment prior to the initiation of dialysis treatment. (Patient #6). Findings include: Record review on 06/18/2024 at 1:35 PM for Patient #6 is revealed Patient #6 was admitted to the dialysis facility on 10/17/2023. Review of the chart revealed the initial RN assessment was completed on 11/20/2023, 33 days post the start of dialysis treatments. During an interview on 06/20/24 at 10:45 AM, the Charge Nurse (CN) verified the findings. Facility policy, entitled “Comprehensive Interdisciplinary Assessment and Plan of Care” reads, “A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs.””

“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: 36779 Based on observation, record review and interview, the dialysis facility failed to ensure patient’s blood pressures were monitored during dialysis treatment for three of seven records reviewed. (Patients #1, #4 and #7). Findings include: Review of Patient 1’s record on 6/18/24 at 1:18 PM revealed Patient #1 was admitted to the dialysis facility on 4/19/24 with a diagnosis of Renal Failure related to Diabetes Mellitus (elevated blood sugar levels). Review of the treatment sheet dated 5/27/24 revealed Patient #1 received dialysis treatment from 12:54 PM to 4:34 PM. Patient #1’s blood pressure was taken at “15:30 (3:30 PM)” and the next time it was taken was “16:34 (4:34 PM)” (one hour and four minutes between blood pressure monitoring). Review of the treatment sheet dated 5/31/24 revealed Patient #1 received dialysis treatment from 12:34 PM to 4:34 PM. Patient #1’s blood pressure was taken at “12:34 (PM)” and the next time it was taken was “13:30 (1:30 PM)” (56 minutes between blood pressure monitoring). During an interview on 6/20/24 at 11:08 AM, the Charge Nurse (CN) reviewed Patient #1’s treatment sheets dated 5/27/24 and 5/31/24 and confirmed the findings stating, “Blood pressure monitoring is supposed to be done every 30 minutes”. During a random observation on 6/18/24 at 10:43 AM, Patient #7 was observed to have shortness of breath with labored breathing, a moist cough and an oxygen canula in place. During an interview on 6/18/24 at 11:00 AM, Registered Nurse (RN) #1 stated Patient #7 “has a lot of fluid on him/her.” Review of Patient #7’s record on 6/19/24 at 11:00 AM revealed Patient #7 was admitted to the dialysis facility on 11/22/19 with a diagnosis of Renal Failure due to Chronic Nephrotic Syndrome with Diffuse Membranous Glomerulonephritis. Review of the treatment sheet dated 6/04/24 revealed Patient #7 received dialysis treatment from 6:49 AM to 11:01 AM. Patient #7’s blood pressure was taken at “07:59 (AM) and the next time it was taken was at “09:02 (AM)” (one hour and three minutes between blood pressure monitoring). Review of the treatment sheet dated 6/08/24 revealed Patient #7 received dialysis treatment from 7:07 AM to 11:10 AM. Patient #7’s blood pressure was taken at “09:08 (AM)” and the next time it was taken was at “10:37 (one hour and twenty-nine minutes between blood pressure monitoring). During an interview on 6/20/24 at 11:52 AM, the CN stated, “ Patient #7 often retained excess fluid”. The CN reviewed Patient #7’s treatment sheets dated 6/04/24, 6/08/24 and 6/13/24 and confirmed the findings stating, “Blood pressure monitoring is supposed to be done every 30 minutes”. Review of Patient #4’s record on 6/19/24 at 9:40 AM revealed Patient #4 was admitted to the dialysis facility on 1/18/16 with Renal Failure caused by Hypertension (high blood pressure) and Chronic Kidney Disease. Review of the treatment sheet dated 6/14/24 revealed Patient #4 received dialysis treatment from 11:49 AM to 2:53 PM. Patient #4’s blood pressure was taken at “14:02 (2:02 PM) and the next time it was taken was at “14:53 (2:53 PM)” (51 minutes between blood pressure monitoring). During an interview on 6/20/24 at 11:28 AM, the CN reviewed the treatment sheet dated 6/14/24 and confirmed the finding stating, “Blood pressure monitoring is supposed to be done every 30 minutes”. Facility policy, entitled, “Patient Assessment and Monitoring” revealed, “...During Treatment...Obtain blood pressure...every 30 minutes or more as needed but not to exceed 45 minutes...”.”

“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: 36779 Based on record review and interview, the dialysis facility failed to ensure the Dialysate Flow Rate (DFR) was administered as prescribed by the physician for 2 of 7 patient charts reviewed. (Patients #4 and #7). Findings include: Review of Patient #4’s record on 6/19/24 at 9:40 AM revealed Patient #4 was admitted to the dialysis facility on 1/18/16 for Renal Failure related to Hypertension and Chronic Kidney Disease. Review of the treatment sheet dated 5/29/24 revealed the physician’s order was for a DFR of 600 ml (milliliters)/min (minute), however the treatment was administered at a DFR of 800 ml/min from 12:28 PM to 1:30 PM and from 2:33 PM to 3:29 PM with no explanation for the change. The treatment sheet dated 5/31/24 revealed the physician’s order was for a DFR of 600 ml/min, however the treatment was administered at a DFR of 800 ml/min from 12:17 PM to 2:30 PM with no explanation for the change. During an interview on 6/20/24 at 11:30 AM, the Charge Nurse (CN) reviewed the treatment sheets and confirmed the findings. Review of Patient #7’s record on 6/19/24 at 11:00 AM revealed Patient #7 was admitted to the dialysis facility on 11/22/19 for Renal Failure related to Chronic Nephrotic Syndrome with Diffuse Membranous Glomerulonephritis. Review of the treatment sheet dated 5/30/24 revealed the physician’s order was for a DFR of 800 ml/min, however the treatment was administered at a DFR of 600 ml/min from 7:01 AM to 10:34 AM with no explanation for the change. Review of the treatment sheet dated 6/06/24 revealed the physician’s order was for a DFR of 800 ml/min, however the treatment was administered at a DFR of 700 ml/min from 7:02 AM to 11:06 AM with no explanation for the change. During an interview on 6/20/24 at 11:52 AM, the CN reviewed the treatment sheets and confirmed the findings. Facility policy, entitled “Patient Monitoring and Safety Checks During Hemodialysis Treatment,” reads, “Verify dialysate lines are attached and in correct position and DFR, BFR, and UFR is set and functioning per treatment physician order”.”