Fresenius Medical Care North Anderson

“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: 22313 Based on observation and interview, the dialysis facility staff failed to follow recognized standards for infection control and sanitization when using equipment brought to the patient treatment area between patients for 1 of 3 Registered Nurses observed. (RN #2). Findings include: Observation on 6/17/24 of the treatment room floor between 10:40 AM to 10:53 AM showed RN #2 wearing a stethoscope around his/her neck, assessing patients and then replacing the stethoscope around his/her neck without sanitizing the equipment. During an interview on 6/20/24 at 10:15 AM, the Clinical Manager stated that “Staff should sanitize equipment before replacing over scrub gowns”. 41743”

“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: 22313 Based on observation, interview and policy review, the dialysis facility staff failed to use Personal Protective Equipment (PPE) properly and perform hand hygiene after glove removal. The findings include: Observation on 6/17/24 at 8:30 AM of the treatment room floor showed Registered Nurse (RN) #2 providing care to a patient at dialysis station #19. RN #2 was called to help the patient at dialysis station #12. RN #2 took off his/her gloves, walked over to dialysis station #12, picked up the edge of his/her gown, wrapped it around his/her hand and touched the dialysis machine keyboard and screen without gloves donned. RN #2 then adjusted the dialysis machine tubing without gloves donned and left the station without performing hand hygiene. Observation on 6/17/24 at 10:30 AM of the treatment room floor showed Certified Clinical Hemodialysis Technician (CCHT) #3 walked away the patient at dialysis station #21 with gloves donned and picked up a paper from the treatment room floor, placed it in the trash can, picked up another piece of trash and disposed of it, grabbed a bleach wipe and walked over to the patient at dialysis station #18 with the same gloves donned. CCHT #3 then discarded and changed gloves and failed to perform hand hygiene before walking back to the patient at dialysis station #21. Observation on 6/17/24 at 11:12 AM showed RN #1 entering the isolation room to begin treatment on a Hepatitis B+ patient with a Central Venous Catheter (CVC). RN # 1 enters the room without a gown, mask or shield donned, performs hand hygiene and dons clean gloves, assesses the patient and begins treatment. RN #1 then doffs the gloves and performs hand hygiene before leaving the room to get supplies. At 11:22 AM, RN #1 re-enters the isolation room after donning a gown, mask and gloves, but performed no hand hygiene and begins the patient’s treatment. During an interview on 06/20/24 10:45 AM the Clinical Manager nodded and stated “I know who that is..” 41743”

“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: 22313 Based on observation and interview, the dialysis facility staff failed to ensure medications were secured properly for 2 of 2 observations. The findings include: Observations on 6/17/24 at 2:00 PM of the treatment floor showed (8) syringes of medications sitting in the east medication area and (2) syringes in the west medication area unattended and the medication refrigerator unlocked. Observation on 6/19/24 at 11:50 AM of the treatment room floor revealed the east medication drawer unattended. During an interview on 06/19/24 10:45 AM the Clinical Manager stated “We have a strict policy on that.” Facility policy, entitled “Medication Preparation and Administration,” dated 05/02/22, shows that all medications must be kept in a locked cabinet except when in use.”

“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: 22313 Based on observation and interview, the dialysis facility staff failed to dispose of and handle infectious waste properly for 2 of 2 staff observed. (Registered Nurse (RN #1) and Certified Clinical Hemodialysis Technician (CCHT #1). The findings include: Observation on 6/17/24 at 11:45 AM of the isolation room revealed RN #1 showed the infectious (red) waste bag container was overfilled beyond the waste container with (2) bloody gauze pads on the floor beside the container. During an interview on 6/17/24 at 12:01 PM, RN #1 stated, “The bag needs to be changed out”. Observation on 6/19/24 at 11:47 AM on the treatment floor showed Certified Clinical Hemodialysis Technician (CCHT #1) discard used tubing in the infectious (red) waste container which was full. CCHT #1 pushed the tubing down into the container with donned gloves with his/her arms visibly down into the container bilaterally. CCHT #1 then discarded the gloves, performed hand hygiene, donned clean gloves and returned to a patients chairside providing care. During an interview on 6/19/24 at 11:55 AM, CCHT #1 stated, “It’s too full, we push it down”. During an interview on 6/20/24 at 10:45 AM, the Clinical Manager stated, “They know to change those bags out”.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 22313 Based on observation, interview and review of facility policy, the dialysis facility staff failed to ensure that dedicated equipment was available for use in the isolation room during dialysis treatment for a hepatitis B positive patient for 2 of 2 Registered Nurse (RN) observations. (RN #1 and RN #3). Findings include: Observation on 6/17/24 at 11:10 AM of the isolation room revealed RN #1 entered the isolation room with a stethoscope around his/her neck and assessed the patient. RN #1 post assessment of the patient placed the stethoscope around his/her neck and exited the room. There was no dedicated stethoscope seen in the isolation room. Observation on 6/19/24 at 11:35 AM of the isolation room revealed RN #3 entered the isolation room with a stethoscope to assess the patient and adjust the dialysis machine. After using the stethoscope on the patient, RN #3 put the stethoscope around his/her neck and used an alcohol wipe to clean the diaphragm before exiting the room. Observation further revealed no dedicated stethoscope in the isolation room. During an interview on 6/20/24 at 11:55 AM, the Clinical Manager stated, “We need some training on this”. During an interview on 06/20/24 10:45 AM, the Clinical Manager stated, “There is supposed to be a dedicated stethoscope in that room”. Facility policy, entitled, “Dialyzing Patients with Positive Hepatitis B” shows that, “All supplies used in the isolation area should be labeled Isolation and not routinely removed”.”

“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: 22313 Based on observations, interview and review of facility policy, the dialysis facility staff failed to disinfect the CVC (Central Venous Catheter) hubs post disconnection from the dialysis lines and prior to medication administration for 1 of 2 Registered Nurses (RN #3) observed. The findings include: Observation on 6/18/24 at 11:30 AM of the treatment room floor revealed a patient at station #17 with post dialysis treatment termination via CVC. Registered Nurse (RN #3) did not disinfect the CVC hub after disconnecting the blood lines and prior to medication administration. RN #3 administered (3) saline and heparin medications from three different syringes in rapid succession without disinfection of the hub in between medications. During an interview on 6/18/24 at 11:40 AM, RN #3 was asked if that is the proper procedure and RN #3 stated, “I don’t normally do it that way”. Observation on 6/18/24 at 12:15 PM of the treatment room floor revealed a patient at station #23 with initiation of dialysis treatment via a CVC. RN #3 scrubbed the CVC hub initially, withdrew 10 milliliters (ml) of blood with two separate syringes from both ports. RN #3 then administered 2 different medications via syringes into the first and second catheter limbs with the endcaps attached post administration. Further observation revealed no disinfection of the CVC hubs between medication administrations. During an interview on 6/18/24 at 12:25 PM, RN #3 responded, “I don’t normally do it that way”. Facility policy, entitled “Central Venous Catheter (CVC) for Initiation and Termination of Treatment,” shows, “Threads and the end of the luer lock (hub) must be scrubbed with a 70% sterile alcohol prep pad or other antiseptic, such as chlorhexidine or providone for 10-15 seconds, and any time caps are removed or bloodlines are disconnected at end of treatment or treatment interruption, to reduce risk of contamination”. Facility policy, entitled “Aphereis Using a Central Venous (Catheter (CVC) for Initiation and Termination of Treatment” dated 05/01/23, showed staff are to sanitize the luer lock hub of CVC catheters for 10-15 seconds with alcohol when caps are removed, or bloodlines are disconnected.”

“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: 41743 Based on observation, interview and policy review, the dialysis facility failed to provide a safe environment for patient by failing to remove expired supplies from staff access per policy and by failing to label bleach bottles used for blood spills. Facility policy, entitled “Expiration Dates Sterile Supplies” dated 07/04/12, showed that expired supplies are not to be used and are to be removed. Findings include: Observations on 06/17/24 between 9:50 AM and 12: PM showed at cleaning stations for east and west bays, unlabeled clear fluid-filled bottles. During an interview on 06/17/24, Patient Care Technician (PCT) #4 stated that the bottles are for blood spills, 1:10 (one to ten) dilution bleach and are filled daily. During an interview on 06/20/24 at 10:15 AM, Clinical Manager stated that they have never labeled these bottles. Observations on 06/17/24 between 12:00 PM and 12:30 PM showed expired supplies in the home training department: Adrenaline vial 1 mg/1 ml expired 02/01/24, two IV (intravenous) administration kits expired 08/31/23 and (13) BD safety glide 1 ml syringes expired 11/30/23. During an interview on 06/17/24 at 12:40 PM, the Home Therapy Manager stated that expired supplies should be removed and verified the findings.”

“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: 22313 Based on observation, interview and policy review, the dialysis facility staff failed to perform proper cannulation of patient’s access for 4 of 4 staff observed, Patient Certified Technician (PCT) #4 and Certified Clinical Hemodialysis Technicians (CCHT) #2, #5 and #6. Facility policy, entitled, “Access Assessment and Cannulation”, dated 07/05/2022, showed that staff or the patient should wash the access site prior to initiating cannulation, staff should disinfect the site using alcohol for 30 seconds and allow alcohol to dry before cannulation, and not touch cannulation site after skin disinfection. Findings include: Observation on 06/17/24 at 11:00 AM showed CCHT #2 performing cannulation of a patient at station #10. CCHT #2 did not wash the patient’s access site, sanitize the access site with alcohol for a full 30 seconds and/or wait for the alcohol to dry. During an interview on 06/20/24 at 10:15 AM, the Clinical Manager stated that cannulation was not done properly. Observation on 06/19/24 at 11:42 AM showed PCT #4 performing cannulation of a patient at station #5. PCT #4 did not wash the access site, used a gloved finger to touch the access site prior to cannulation and did not sanitize the access site with alcohol for a full 30 seconds and/or wait for the alcohol to dry. During an interview on 06/20/24 at 10:15 AM, Clinical Manager stated that cannulation was not done properly. Observation on 06/19/24 at 11:47 AM showed CCHT #5 performing cannulation of patient at station #6. CCHT #5 did not sanitize the access site with alcohol for a full 30 seconds and/or wait for the alcohol to dry prior to cannulation. During an interview on 06/20/24 at 10:15 AM, Clinical Manager stated that cannulation was not done properly. Observation on 06/18/24 12:30 PM, Certified Clinical Hemodialysis Technician (CCHT) #5 attempted to cannulate the patient’s access. The patient flinched and CCHT #5 jerked the needle out, felt for the access site again with an unsterile glove and re-inserted the needle into the same spot. On 06/18/24 at 12:51 PM, CCHT #5 remarked “I should’ve started over”. Review of Facility policy titled “Access Assessment and Cannulation,” dated 07/05/22, reads “perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection. Same sites should not be re-cannulated for at least two weeks. New sites should be at least ¼ inch away from the last puncture site”. 41743”