Fresenius Medical Care of Fairfield

“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: 44675 Based on observations, facility documentation, facility policy and interviews, the facility failed to provide a clean and sanitary environment. The findings include: Flash tour observations conducted of the facility treatment floor on 10/28/24 at 9:30 AM identified the following: 1. Station #’s 2, 3, 4 and 8’s wallbox (contains connections for the dialysis machine to receive acid and base concentrations, treated water and dispose of waste products) had a crusted white/yellow substance throughout the inside. There was white crusted splatter throughout the wall around the wallbox and the outlets were rusted. The wall around the wallbox was warped at the bottom and deteriorating. 2. Station #6’s wallbox had a crusted white/yellow substance throughout the inside. There was white crusted splatter throughout the wall around the wallbox and the outlets were rusted. The wall around the wallbox was warped at the bottom and deteriorating. There was tape throughout the wall. 3. Station #’s 9, 10, 11, 12, 13, 14, 15, 16, 18 and 19’s wallbox had a crusted white/yellow substance throughout the inside. There was white crusted splatter throughout the wall around the wallbox and the outlets were rusted. 4. The clean sink by Station #17 had a yellow/white substance crusted on the counter. 5. There was tape stuck on the counters throughout the treatment floor, including the medication preparation area. 6. There was brown discolored tape on the Hoyer lift. Observations conducted on 10/29/24 at 10:00 AM identified the observations conducted on 10/28/24 remained present throughout the treatment floor. Interview with the Clinical Manager on 10/29/24 at 1:00 PM identified the wall boxes are to be cleaned and disinfected every night. She identified they facility is putting a plan into place to address the laminate walls around the wall boxes. Review of the cleaning and disinfection of the dialysis station directed dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. Special attention should be given to removing build-up and/or cleaning splatter and spray of concentration solution. If concentrate leaks are noted at the wall box, staff should notify biomedical services.”

“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: 47491 Based on observations, facility documentation, facility policy and interviews, the facility failed to ensure patients removed their gloves and were offered hand hygiene prior to leaving the treatment floor. The findings included: Observations conducted on 10/29/24 at 9:48 AM identified Patient #6 removing the glove from his/her right hand, after holding his/her left hemodialysis access following hemodialysis treatment, without performing hand hygiene. Patient #6 was observed walking to the scale to be weighed with Staff Person #1 following him/her and opened the door to leave the clinic without being asked or offered hand sanitizer. Interview with Staff Person #1 on 10/29/24 at 10:25 AM identified hand hygiene should be performed before and after glove removal and that he/she had missed the opportunity to provide/offer Patient #6 hand sanitizer after removing his/her glove and leaving the clinic. Observations conducted on 10/29/24 at 10:10 AM identified Patient #7 removing the glove from his/her right hand, after holding his/her left hemodialysis access following hemodialysis treatment, without performing hand hygiene. Patient #7 was observed walking throughout the treatment floor, going to his/her locker to store his/her blanket, walking to the scale to get weighed, and then opening the door to leave the clinic, all without performing hand hygiene. Interview with Staff Person #2 on 10/29/24 at 10:37 AM identified Patient #7 should have performed hand hygiene immediately after removing his/her glove and that it was the staff’s responsibility to ensure the patient performed hand hygiene. Staff Person #2 further indicated he/she didn’t follow up with the patient to ensure that hand hygiene was performed. Review of the Hand Hygiene policy directed hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water immediately after removing gloves.”

“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: 41746 Based on observation during tour on 10/28/24 at 09:45 AM, the surveyor while accompanied by the Bio Med Technician, and the Area Bio-Med Technician Manager, the facility failed to maintain a safe environment. The findings include the following: The facility does not provide a separate closet for the storage of oxygen cylinders, as required by Section # 19-13-D55a (m)(6)(H) of “CT Public Health Code”; i.e.: Closet in back hallway that oxygen was store in had combustible materials stored in it and there was no signage to identify that oxygen was stored inside. The facilities exits are not being maintained at all times, as required by section #’s 7.1 & 21.2.1 of the “Life Safety Code” i.e.: The rear corridor had boxes and equipment stored in it and the path of egress was not maintained and ready for use as required, as required. The facility did not ensure that the treatment areas were maintained clean, in good repair, Ie, the dialysis machines had a film on them, appearing unclean and unkempt.”

“PE-LSC-SPRINKLERS CFR(s): 494.60(e)(2) (2) Notwithstanding paragraph (d)(1) of this section, dialysis facilities participating in Medicare as of October 14, 2008 that require sprinkler systems are those housed in multi-story buildings construction Types II(000), III(200), or V(000), as defined in the Life Safety Code, section 21.1.6.1, which were constructed after January 1, 2008, and those housed in high rise buildings over 75 feet in height, which were constructed after January 1, 2008. This Standard is not met as evidenced by: 41746 Based on observation during document review on 10/28/24 at 11:00 AM, the surveyors were not provided with documentation from the Biomed Tech or the Clinical Manager, to show that the facility is maintaining the automatic sprinkler system in accordance with NFPA 25. Ie. 5 year obstruction test has been conducted as required by section # 5.1.1.2 of NFPA 25, “Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems”. Reports show last obstruction test was done 05/19.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47491 Based on review of clinical records, interviews and review of facility documents for one (1) of two (2) patients (Patient #2) reviewed for vital signs, the facility failed to ensure an ambulatory patient had a post-treatment standing blood pressure in accordance with facility policy. The findings included: Patient #2 had diagnoses that included end stage renal disease, an order for hemodialysis treatments three (3) times weekly for four (4) hours, at a blood flow rate (BFR) of 450, a dialysate flow rate set on Autoflow, using a left upper arm arteriovenous fistula. Review of Patient #2’s treatment records identified the following: 1. Review of Patient #2’s hemodialysis flowsheets dated 10/11/24, 10/18/24, and 10/25/24 identified Patient #2 was ambulatory with an assistive device, however failed to identify a post-treatment standing blood pressure and reason the post-treatment standing blood pressure was not obtained. Interview with the Director of Operations on 10/29/24 at 2:20 PM identified post-treatment standing blood pressures should be taken every treatment and if not, the reason should be documented in the patient’s treatment record. Review of the Patient Assessment and Monitoring policy directed to ensure vital signs and overall condition of the patient were stable for discharge.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 47491 Based on clinical record review, facility documentation, and interview for one (1) patient reviewed for peritoneal dialysis, (Patient #4), the facility failed to ensure the facility verified that the appropriate dialysate concentrations were used with each treatment. The findings included: Patient #4 had diagnoses including end stage renal disease, an order for daily peritoneal dialysis treatments, utilizing varied dialysate concentrations and an abdominal dialysis catheter. Review of Patient #4’s electronic treatment records dated August 2, 2024 through October 26, 2024 failed to identify the specific dialysate solution concentrations used with each treatment. Interview with the Staff Person #3 on 10/29/24 at 11:08 AM identified that although Patient #4’s treatment sheets were reviewed monthly during clinic visit, he/she had not realized that the patient was not entering the specific dialysate concentrations used with treatment. Interview with the Peritoneal Dialysis Clinic Manager on 10/29/24 at 11:00 AM identified peritoneal dialysis patients were trained to enter the dialysate solutions used with treatments into the hub of the dialysis machine, however Patient #4 had vascular issues which prevented him/her from being able to do this and that his/her spouse was being trained to do this for the patient. The Peritoneal Dialysis Clinic Manager further identified on 10/29/24 at 11:10 AM that the peritoneal dialysis nurse was unable to verify the patient was following his/her fluid guidelines as the dialysate used was missing from the electronic treatment records and that the peritoneal dialysis nurse would now review the patient’s treatment sheets to ensure the patient is following this/her treatment fluid guidelines. Review of the Clinic Visits for Home Dialysis Patients policy directed home treatment records , self-monitoring data and other information recorded by the patient or designated care partner would be reviewed for completeness, trends, accuracy and appropriateness.”

“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: 44675 Based on observations, facility documentation, facility policy and interviews, the facility failed to ensure a patient (Patient #8) receiving hemodialysis treatment had their hemodialysis access visible at all times, failed to ensure that expired medications were discarded in accordance with facility policy, failed to ensure that the emergency evacuation kit was secured and lock per facility policy, failed to perform daily glucometer checks and calibrations to glucometers available for use on the clinic floor, and failed to administer patients hemodialysis treatment (Patient #1 and #2) was administered at the prescribed blood flow rate. . The findings included: 1. Patient # 8 had diagnoses that included end stage renal disease, a central venous catheter (CVC) in the upper right chest, a physician’s order for hemodialysis three (3) times weekly for three (3) hours per treatment, utilizing a 3.0 potassium/ 2.5 calcium dialysate bath, at a blood flow rate of 400, and dialysate flow rate of autoflow 1.5. Observation of Patient #8 while receiving treatment on 10/29/24 identified the following: a. At 12:00 PM, surveyor identified Patient #8’s CVC was covered completely by a chux pad (a blue absorption pad ). b. At 12:06 PM, surveyor identified Staff Person #4 attending to Patient #8’s dialysis machine and did not address the covered access. c. At 12:07 PM, Staff Person #4 adjusted Patient #8’s blood pressure cuff and did not address the covered access. d. At 12:08 PM, Staff Person #4 finished entering information into Patient #8’s dialysis machine and left the patient’s station without checking his/her access or uncovering the access site. Interview with Staff Person #4 on 10/29/24 at 12:10 PM identified Patient #8’s access site was still covered as Staff Person #4 had to uncover the site to show the surveyor where the vascular access was located. Staff Person #4 identified he/she was unable to see the access site as it was sealed from view by the chux. Staff Person #4 further identified that he/she did not check the access when at the patient’s machine, that he/she was supposed to check the access when reviewing vitals, and each time the patient’s station was entered. Staff Person #4 indicated he/she did not check the access site as he/she didn’t think there was an issue or concern, however identified access sites should always be visible. Interview with the Medical Director on 10/29/24 at 1:53 PM identified a hemodialysis access should always be visible throughout a patient’s treatment to check for issues or bleeding, and that there is a risk for dislodgement and exsanguination if the access was not visible and/or assessed. The Medical Director further identified the expectation that staff check/assess the access each time the patient’s station is entered and when reviewing vitals, as it is part of the overall assessment. Review of the Patient Assessment and Monitoring policy directed staff to ensure the access remains uncovered throughout the patient’s treatment. 2. Observations conducted on 10/28/24 at 9:30 AM during a flash tour of the facility identified the emergency evacuation kit was unlocked. Review of the emergency medications, equipment and supplies policy directed that the emergency cart must be locked when not in use. Observation conducted on 10/29/24 at 10:00 AM identified the emergency evacuation kit remained unlocked. 3. Observations conducted on 10/28/24 at 10:00 AM during a flash tout of the facility identified the crash cart contained two (2) 100 mg vials of Solu-Cortef ( a steroid medication used to treat allergic reactions, breathing problems, arthritis, and blood diseases) with an expiration date of 9/2024. Interview with the Charge Nurse on 10/28/24 at 10:05 AM identified expired medications should be disposed of by the expiration date of the medication, which in this case should have been by 9/30/24. The Charge Nurse further identified staff responsible for performing audits of the crash cart had missed checking the expiration date of the medication. Review of the Medication Preparation and Administration policy directed all medications were to be monitored on a monthly basis and that expired medications were to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state law. 4. Observations on 10/28/24 at 10:15 AM identified three (3) glucometers in the drawers of the staff prep/workstation on the treatment floor and one (1) glucometer in a drawer at the nurse’s station. Review of the glucometer Reading Results sheets dated 10/23/24 through 10/30/24 identified test results for one (1) glucometer were completed, however did not specify which glucometer was tested. Interview with the Facility Administrator on 10/28/24 at 10:20 AM identified staff was only testing/calibrating one (1) glucometer daily, which was placed on the workstation counter for use following testing. However, the facility administrator identified the facility had four (4) glucometers total, could not confirm the tested/calibrated glucometer was located on the workstation counter for use, and could not identify which glucometer was tested/calibrated that day. The Facility Administrator further identified that each glucometer should be tested/calibrated daily and that only one (1) glucometer was tested/calibrated daily as the glucometer Reading Results sheets indicated data for only one (1) glucometer. Review of the Blood Glucose Monitoring Device policy directed calibration and control testing to be performed each operating day that patients were present, when a new bottle of test strips was opened, and to record test results in the electronic documentation system. 5. Patient #1 was admitted to the facility with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and forty-five (45) minutes with a right upper arteriovenous fistula (AVF), fifteen (15) -gauge needs, a Dialysate Flow Rate (DFR) of 500 and Blood Flow Rate (BFR) of 400. A sample review of Patient #1’s treatment flowsheets identified the following: a. On 10/8/24 Patient #1’s AVF was cannulated successfully and treatment was started at 7:09 AM and Patient #1’s BFR was 300 with no rationale as to why the prescribed BFR of 400 was not met. At 9:30 AM Patient #1’s BFR was increased to 450 with no rationale as to why the prescribed BFR of 400 was not followed. b. On 10/10/24 Patient #1’s AVF was cannulated successfully, however for the entirety of the treatment Patient #4’s BFR was 300 with no rationale as to why the prescribed BFR of 400 was not met. c. On 10/15/24 Patient #1’s AVF was cannulated successfully, however for the entirety of the treatment Patient #4’s BFR was 450 with no rationale as to why the prescribed BFR of 400 was not followed. Review of the nursing notes failed to identify documentation of why Patient #1’s hemodialysis prescribed BFR was not achieved. 6. Patient #2 had diagnoses that included end stage renal disease, an order for hemodialysis treatments three (3) times weekly for four (4) hours, at a blood flow rate (BFR) of 450, a dialysate flow rate set on Autoflow, using a left upper arm arteriovenous fistula. Review of Patient #2’s treatment records identified the following: a. On 10/11/24, Patient #2’s treatment was run at a BFR of 400 instead of the prescribed BFR of 450 for one (1) hour and fifty-four (54) minutes of treatment without notation of the reason for the change/adjustment. b. On 10/23/24, Patient #2’s treatment was run at a BFR of 400 instead of the prescribed BFR of 450 for fifty-five (45) minutes of treatment without notation of the reason for the change/adjustment. c. On 10/25/24, Patient #2’s treatment was run at a BFR of 420 instead of the prescribed BFR of 450 for two (2) hours of treatment without notation of the reason for the change/adjustment. Interview with the Director of Operations on 10/29/24 at 2:20 PM identified the physician should be contacted when a BFR cannot be attained, to obtain a new order, and that staff was to document the reason why the BFR could not be achieved. Review of the Patient Assessment and Monitoring policy directed to check if the prescribed blood flow rate is being achieved or to document the reason if unable to meet the prescribed blood flow rate. Review of the patient assessment and monitoring policy directed during treatment to check that the prescribed blood flow is being achieved or the reason is documented in the medical record if unable to meet prescribed blood flow. Check that the dialysate flow rate setting is correct, and the prescribed flow is being delivered.”