Fall River Kidney Center LLC

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 10249 Based on observations, record reviews, staff interviews, and policy reviews, the facility failed to ensure that the condition of infection control was met. Seven of twelve facility staff observed, (Registered Nurse [RN] #5, Certified Clinical Hemodialysis Technician [CCHT] #1, CCHT #5, CCHT #7, CCHT #9, CCHT #11, and CCHT #12), failed to perform adequate infection control measures to ensure the health and safety of all patients. Findings Include the following: 1. The facility failed to provide a sanitary environment to minimize the transmission of infectious agents within the water treatment room. Refer to V111. 2. The facility failed to ensure that 2 staff members (CCHT #9, and CCHT #11) implemented adequate infection control measures, related to glove use and hand hygiene, while caring for patients and touching patient equipment. Refer to V113. 3. The facility failed to ensure that 2 staff members (CCHT #1, and CCHT #11) wore personal protective equipment appropriately when there was a risk of blood splatter 1.) during initiation of dialysis treatment for 2 patients (#11 and #12) with an arteriovenous fistula (AVF); and 2.) during termination of dialysis treatment for 1 patient (#19) with a Central Venous Catheter (CVC). Refer to V115. 4. The facility failed to ensure the separation of clean and dirty items on the treatment floor to reduce the risk of cross contamination and spread of infections. Specifically, 1 staff member (CCHT #9) potentially contaminated the clean supply cart when she failed to perform hand hygiene after removing gloves and then retrieving new gloves from the cart, and 1 staff member (RN #5) potentially contaminated the clean medication preparation area when she failed to remove her gown prior to entering. Refer to V117. 5. The facility failed to 1.) ensure 2 of 4 staff members observed (CCHT #11 and CCHT #9) adequately disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens; and 2.) ensure that bleach containers remained covered to maintain efficacy of the bleach solution. Refer to V122. 6. The facility failed to ensure timely administration of the Hepatitis B vaccine series for 1 susceptible patient (#8). Refer to V126. 7. The facility failed to ensure 3 of 5 staff members (CCHT #1, CCHT #5, and CCHT #11) observed adequately disinfected the cannulation sites prior to initiating dialysis treatment for 2 of 4 patients (#11 and #8) with an arteriovenous fistula/graft (AVF/G). Refer to V142. 8. The facility failed to 1.) ensure 2 of 4 staff members (RN #5 and CCHT #12) implemented adequate infection control measures during exit site care to minimize the risk of infection for 2 of 2 patients (#18 and #13); and 2.) ensure 1 of 4 staff members (CCHT #7) implemented adequate infection control measures during termination of treatment for 2 of 4 patients (#18 and #4) with a Central Venous Catheter (CVC). Refer V147.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 44223 Based on record review, staff interview, and policy review, the facility failed to ensure 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #3) received Emergency Preparedness Training as required, out of a total sample of 5 staff reviewed. Findings Include: Review of the facility policy titled, Disaster and Emergency Preparedness, revision date 6/1/23 indicated the following: *The center Manager or designee will ensure: *All center associates are in-serviced during orientation and annually thereafter in general disaster procedures and how to provide instruction to patients on what to do in the event of an emergency. *In-services will be documented on the Training/In-service Documentation Form. Review of personal record indicated that CCHT #3 had a hire date of 11/6/23. Review of CCHT #3’s education record did not indicate the last time that CCHT #3 received Emergency Preparedness training, nor did the record indicate that Emergency Preparedness Training had been conducted on orientation or annually. During an interview on 3/12/25 at 2:50 P.M., the Clinic Manager (CM) said the Emergency Preparedness Training was not completed by CCHT #3 as required. As a result, the facility failed to comply with Emergency Preparedness Training requirements.”

“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: 37349 Based on observations and staff interview, the facility failed to provide a sanitary environment to minimize the transmission of infectious agents within the water treatment room. Findings include: During a tour of the water treatment room on 3/12/25 at 7:15 A.M., the Biomedical Technician and the surveyor observed the following in the water treatment room: * Along the wall between the booster pump and sediment filter was a red bucket below a port with approximately an inch of water, behind the bucket the wall was damaged with exposed sheet rock. On the wall and floor, in the area there was a black irregular shaped substance with a fuzzy raised texture. * Along the wall, between the reverse osmosis (RO) equipment and the RO storage tank, was an area damaged with cracked wood and loose molding, which did not meet the floor, leaving an approximately 1 inch gap from the floor to the wall. * The base of the RO storage tank was laden with dust and covered with thick cob webs. * Behind the RO storage tank, the floor was covered with a thick layer of dirt and debris. * The cement floor in the water room had cracks, and loose areas of cement creating large divots. The divots were filled with dirt and debris. * Ceiling tile above the carbon tanks were discolored with a brown stain. During an interview on 3/12/25 at 7:15 A.M., the Biomedical Technician said he was aware of the condition of the walls and floors in the water room. He said someone had been in to look at it sometime around February 2024, but he did not know the current status. During an interview on 3/12/25 at 8:20 A.M., the Clinic Manager (CM) said she was aware of the condition of the walls and floors in the water room. She said she received quotes for repairs and it was brought to the Governing Body some time ago, but not recently. During an interview on 3/12/25 at 10:05 A.M., the Biomedical Technician said he is responsible for the cleaning of the water room. He said he tries to sweep it once a month, but should probably get a mop in there. Refer to V751.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #9, and CCHT #11) implemented adequate infection control measures related to glove use and hand hygiene, while caring for patients and touching patient equipment. Findings include: Review of the facility policy titled, Infection Control, last revision 11/29/22, included the following: *Gloves are required whenever caring for a patient or touching the patient’s equipment or supplies. * Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions and contaminated items. 1. On 3/12/25 at 9:25 A.M., the surveyor observed CCHT #11 providing care to a patient in station 8. Upon completion, she removed her gloves and without performing hand hygiene she moved to a computer on wheels, then touched the computer keyboard. She then went back to station 8, where the patient was still seated with a clamp in place, and with bare hands she repositioned the dialysis machine. Without performing hand hygiene she went back to the computer. During an interview on 3/12/25 at 9:25 A.M., CCHT #11 said she should wash her hands when she removes gloves and she should not touch patient equipment with bare hands. 2. On 3/12/25 at 9:45 A.M., the surveyor observed CCHT #9 discontinue dialysis treatment for a patient in station 18. Upon completion she removed her gloves and without performing hand hygiene she walked to the clean supply cart in the center of the area and retrieved and donned another pair of gloves. She proceeded to remove the used dialyzer and dialysis tubing system from the dialysis machine at station 18 and then disposed of it in the biohazard container in the center of the room. She then removed her gloves, and without performing hand hygiene, moved to a computer on wheels and began documenting on the keyboard. Upon completion she again went to the clean supply cart, and without performing hand hygiene, she retrieved and donned a pair of gloves. Next, she assisted the patient from station 18 to the scale, using the potentially contaminated gloves to turn the scale on. She removed the gloves, and without performing hand hygiene used a calculator and pen from the area. During an interview on 3/12/25 at 10:20 A.M., CCHT #9 said she should sanitize her hands when she changes her gloves. During an interview on 3/12/25 at 11:45 A.M., the Clinic Manager said that staff should perform hand hygiene between gloves changes, and should not retrieve supplies from the clean supply cart with potentially contaminated hands.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1, and CCHT #11) wore personal protective equipment appropriately when there was a risk of blood splatter 1.) during initiation of dialysis treatment for 2 patients (#11 and #12) with an arteriovenous fistula (AVF) and; 2.) during termination of dialysis treatment for 1 patient (#19) with a Central Venous Catheter (CVC). Findings include: 1. Review of the facility policy and procedure titled, AVF Cannulation Treatment, Initiation and Termination, last revised 6/20/24, included the following: * The patient caregiver will perform hand hygiene and don clean gloves, full face protection and a fluid-resistant gown. On 3/11/25 at 11:00 A.M., the surveyor observed CCHT #1 initiate dialysis treatment for Patient #11. During the procedure none of the buttons of CCHT #1’s gown were buttoned, exposing the front of her shirt and pants. On 3/11/25 at 11:15 A.M., the surveyor observed CCHT #1 initiate dialysis treatment for Patient #12. During the procedure none of the buttons of CCHT #1’s gown were buttoned, exposing the front of her shirt and pants. During an interview on 3/11/25 at 2:40 P.M., CCHT #1 said her gown should be buttoned when she is performing an initiation of dialysis treatment. 10249 2. Review of the facility policy titled, CVC Assessment and Site Care, last revised 10/22/24, indicated the following: *When any CVC procedure is being performed, the patient caregiver and anyone assisting/observing must wear required personal protective equipment (PPE), including a full-face shield and mask, or safety goggles and a mask. The patient must also wear a mask during the procedure. On 3/11/25 at 2:25 P.M., the surveyor observed CCHT #11 discontinue dialysis treatment for Patient #19. During the procedure CCHT #11 was not wearing goggles or a full face shield. During an interview on 3/11/25 at 2:45 P.M., CCHT #11 said she did not wear her goggles while discontinuing the treatment for Patient #19.”

“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: 37349 Based on observation, interview, and policy review, the facility failed to ensure the separation of clean and dirty items on the treatment floor to reduce the risk of cross contamination and spread of infection. Specifically, 1 staff member (Certified Clinical Hemodialysis Technician [CCHT] #9) potentially contaminated the clean supply cart when she failed to perform hand hygiene after removing gloves and then retrieving new gloves from the cart, and 1 staff member (Registered Nurse [RN] #5) potentially contaminated the clean medication preparation area when she failed to remove her gown prior to entering a clean area. Findings include: Review of the facility policy titled, Infection Control, last revised 11/29/22, included the following: * Each center will maintain and clearly label separate clean and dirty work areas. Clean items, such as medications and gloves are kept in the designated clean areas. 1. The facility failed to ensure CCHT #9 sanitized her hands after removing her gloves and and then retrieving items from a clean supply cart, increasing the risk of cross contamination. On 3/12/25 at 9:45 A.M., the surveyor observed CCHT #9 discontinue dialysis treatment for a patient in station 18. Upon completion she removed her gloves and without performing hand hygiene she walked to the clean supply cart in the center of the area and retrieved and donned another pair of gloves. She proceeded to remove the used tubing from the dialysis machine at station 18 and dispose of it in the biohazard container in the center of the room. She then removed her gloves, and without performing hand hygiene moved to a computer on wheels and began documenting on the keyboard. Upon completion she again went to the clean supply cart and without performing hand hygiene, she retrieved and donned a pair of gloves. She next assisted the patient from station 18 to the scale, using the potentially contaminated gloves to turn the scale on. She removed the gloves, and without performing hand hygiene used a calculator and pen from the area. During an interview on 3/12/25 at 10:20 A.M., CCHT #9 said she should have sanitized her hands when she changed her gloves. During an interview on 3/12/25 at 11:45 A.M., the Clinic Manager said the supply cart is considered clean and staff should not retrieve items from it with potentially contaminated hands. 2. RN #5 failed to remove her gown before entering a clean medication preparation area increasing the risk of cross contamination. On 3/12/25 at 10:55 A.M., the surveyor observed RN #5 enter the heparin preparation area wearing a gown that had been worn while caring for patients on the treatment floor. RN #5 prepared the heparin and proceeded to administer it to the patient in station 10. During an interview on 3/12/25 at 11:15 A.M., RN #5 said the heparin preparation station is a clean area and she should have removed her gown before entering.”

“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: 10249 Based on observation, staff interview, and policy review, the facility failed to 1.) ensure 2 of 4 staff members observed (Certified Clinical Hemodialysis Technician [CCHT] #11 and CCHT #9) adequately disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens; and 2.) ensure that bleach containers remained covered to maintain efficacy of the bleach solution. Findings include: 1. The facility failed to ensure that CCHT #11 and CCHT #9 adequately cleaned and disinfected contaminated surfaces within the dialysis station. Review of the facility policy titled, Cleaning and Disinfection of Equipment, Supplies and Treatment Area, last revised 6/20/24, indicated the following: *Purpose: to prevent transmission of infectious agents in the dialysis center. *Unless equipment manufacturers specify us of another agent, equipment, treatment area and work surfaces will be disinfected using 1:100 bleach/water solution using 5.25%-6%. *Bleach solutions for this purpose must be made fresh each day and all containers are labeled per Risk Management policies for labeling chemical containers and must be covered with a lid to prevent contamination. *All routinely touched reusable equipment and surfaces in the patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but not limited to the: -Dialysis machine, chair including the top and bottom of the chair-side table(s), bedside tables, television, phone, counters and wall boxes. - Dialysis chairs will be reclined, and all areas inspected and disinfected where blood could accumulate and not be readily noticed. -Reusable supplies contaminated with visible blood must be cleaned per this policy and then disinfected, using the bleach/water solution specified in this policy. a. During an observation on 3/11/25 at 10:05 A.M., the surveyor observed CCHT #11 disinfect station 40. She was observed disinfecting the hemodialysis machine and hemodialysis chair with 1:100 bleach soaked pads. CCHT #11 failed to disinfect the 4 hooks, which were located on top of the IV pole. CCHT #11 failed to disinfect the stethoscope that was hanging from a hook on the IV pole. CCHT #11 failed to disinfect the right side of the dialysis machine, including the basket that holds the blood pressure cuff. She failed to disinfect the TV and TV arm, counter, walls and wall box, all located behind the dialysis chair and machine. During an interview on 3/11/25 at 10:22 A.M., CCHT #11 said the patient did not use the television so she did not feel she needed to clean it. CCHT #11 also said she does not clean the counter and wall box until the end of the day. b. During an observation on 3/12/25 at 10:05 A.M., the surveyor observed CCHT #9 disinfect station 18. She was observed disinfecting the hemodialysis machine and hemodialysis chair with 1:100 bleach soaked pads. The seat area of the hemodialysis chair was cracked, exposing cloth like material. During an interview on 3/12/25 at 10:19 A.M., CCHT #9 said she used bleach soak clothes to disinfect the seat of the dialysis chair. During an interview on 3/12/25 at 4:15 P.M., the Clinical Regulatory Manager (CRM) said that the hemodialysis chair surface needs to be intact to ensure adequate disinfection. 2. The facility failed to ensure bleach solution was stored in a closed container to maintain efficacy. During an observation on 3/12/25 between 9:45 A.M. and 10:03 A.M., and again between 10:20 A.M. and 10:40 A.M., the surveyor observed a 1:100 bleach solution container, located in the dirty sink area, not covered with a lid. During an interview on 3/12/25 at 4:10 P.M., the CRM said the containers, containing the 1:100 bleach solution, should be covered at all times. During an interview on 3/12/25 at 4:15 P.M., Registered Nurse #4 said the bleach container should be covered. 37349”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 31240 Based on record review, policy review, and staff interview, the facility failed to ensure timely administration of the Hepatitis B vaccine series for 1 susceptible patient (#8) out of 10 patient records reviewed, from a total sample of 19 patients. Findings include: According to the Center for Disease Control (CDC), Hepatitis B vaccination is recommended for all susceptible chronic hemodialysis patients and staff members, whether or not the facility accepts HBV (hepatitis B virus-a serious liver infection caused by hepatitis) positive patients. Review of the facility’s policy entitled, Hepatitis B: Control and Management, revised 12/22/23, indicated the following: * On an ongoing basis, patients are considered to be susceptible to Hepatitis B if their: -Hepatitis B Surface Antigen (HBsAg: a protein found on the surface of the hepatitis B virus) are determined to be negative, or non-reactive, and -Anti-Hepatitis B surface antibody (Anti-HBs) are determined to be negative or indeterminate, as defined by the lab testing. * Patients considered susceptible to Hepatitis B will be offered the Hepatitis B vaccine series if the have not previously received 2 full vaccine series. Review of the facility’s policy entitled, Vaccines, revised 4/8/23, indicated the following: * Per Federal regulations, Vaccine Information Sheets (VIS) are provided to patients for the following vaccine: Hepatitis B. * Prior to receiving each dose of vaccine, the nurse will provide the patient with the most recent VIS (available for the Centers for Disease Control Prevention (CDC) for the vaccine being administered. The patient must receive the information and sign the Vaccine Consent/Denial VIS Acknowledgement Patient form prior to receiving the dose of the vaccine. * Upon completion, the Vaccine Consent/Denial VIS Acknowledgement Patient form is filed in the designated section of the patient’s medical record. Patient #8 was admitted to the facility in August 2022 with a diagnosis of End Stage Renal Disease, requiring hemodialysis treatments 3 times a week. Review of Patient #8’s Vaccine Record, indicated the following: * Engerix-B (hepatitis B vaccine) due date was 3/14/23, and the patient declined it without explanation. Review of the most recent nursing Comprehensive Assessment, dated 8/1/24, indicated the following; * Hepatitis B surface antigen: Negative (7/2/24). * Has patient ever received hepatitis B vaccine series: No. * Is patient susceptible (HBsAB less than 10): Yes. Review of the facility’s Hepatitis B Summary Report indicated Patient #8’s most recent hepatitis B antibodies (most recent) were less than 4 and the hepatitis vaccine was declined. Review of Patient #8’s Lab Flowsheet indicated the following: * Hepatitis B surface Ab was less than 4 on 1/9/25 * Hepatitis B surface Ag was on 3/6/25. Review of the clinical record indicated no evidence of a signed Vaccine Consent/Denial VIS Acknowledgement Patient form. During an interview on 3/11/25 at 2:20 P.M., the Clinical Regulatory Manager said there was no documentation in the medical record to indicate that the patient had been educated on the benefits of receiving the vaccine and the risks associated with not receiving. She said there was not a Vaccine Consent/Denial VIS Acknowledgement Patient form in Patient #8’s clinical record, but there should have been. She said the only documented evidence of his/her refusal was on the patient’s vaccine record.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 37349 Based on observation, interview, and policy review, the facility failed to ensure 3 of 5 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1, CCHT #5 and CCHT #11) observed adequately disinfected the cannulation sites prior to initiating dialysis treatment for 2 of 4 patients (#11 and #8) with an arteriovenous fistula/graft (AVF/G), out of a total sample of 19 patients. Findings include: Review of the facility policy and procedure, titled AVF-AVG Cannulation, Treatment Initiation and Termination, last revised 6/20/24, included the following: *The access will be washed with antibacterial soap and water or skin antiseptic wipe, prior to preparing the site for cannulation. * Each needle insertion site is disinfected according to manufacturer’s instructions 70% alcohol. * If the access is touched after being disinfected, it must be disinfected again before needle insertion. Review of the directions for use on the back of the 70% alcohol prep pad included the following: * Wipe injection site vigorously and discard. 1. On 3/11/22 at 11:00 A.M., the surveyor observed CCHT #1 initiate treatment for Patient #11, with an AVF, in station 18. CCHT #1 failed to disinfect each needle site, instead she disinfected both sites with an alcohol prep pad using an up and down motion alternating between the upper and lower sites for 10 seconds. She then used a second alcohol prep pad and used the same up and down motion to disinfect for 10 seconds. She applied a tourniquet and then used a third alcohol prep pad and used the up and down motion to disinfect for 10 seconds. She then cannulated the bottom needle site, then the top needle site. The top needle cannulation was not successful and CCHT #1 requested assistance from another staff member. During an interview on 3/11/25 at 2:40 P.M., CCHT #1 said that each cannulation site should have been disinfected separately. 2. On 3/11/25 at 11:25 A.M., after an unsuccessful cannulation attempt by CCHT #1, the surveyor observed CCHT #5 assist with initiation of treatment for Patient #11, with an AVF, in station 18. CCHT #5 disinfected the upper access site with an alcohol prep pad for 5 seconds and discarded the pad on the tray table. She then re-palpated the site, picked up the alcohol pad from the tray table and used it to pass over the site with a single swipe. She kept the wipe in her hand, repalpated the site and used the same alcohol pad over the site with a single swipe. She palpated the site and used the same pad 3 more times and then cannulated. During an interview on 3/11/25 at 12:35 A.M., CCHT #5 said that she used the front and back of the alcohol pad, but normally uses a new alcohol prep pad for each disinfection. During an interview on 3/11/25 at 12:10 P.M., the Clinic Manager said alcohol prep pads should not be reused, and they should be discarded after a single use. 10249 3. On 3/11/25 at 11:15 A.M., the surveyor observed CCHT #11 initiate treatment for Patient #8 at station 39. Patient #8 entered the dialysis station and CCHT #11 proceeded to initiate treatment. The surveyor did not observe Patient #8 wash his/her own access site prior to entering the station, nor did the surveyor observed CCHT #11 wash the patient’s access site prior to disinfecting the area before cannulation, per facility policy. During an interview on 3/11/25 at 11:35 A.M., CCHT #11 said Patient #8 did not wash his/her own access cites with soap and water. CCHT #11 also said she did not wash the area or use the antiseptic wipes prior to disinfecting the area in preparation for cannulation.”

“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: 37349 Based on observation, interview and policy review, the facility failed to 1.) ensure 2 of 4 staff members (Registered Nurse [RN] #5 and Certified Clinical Hemodialysis Technician [CCHT] #12) implemented adequate infection control measure during exit site care to minimize the risk of infection for 2 of 2 patients (#18 and #13) and 2.) ensure 1 of 4 staff members (CCHT #7) implemented adequate infection control measures during termination of treatment for 2 of 4 patients (#18 and #4) with a Central Venous Catheter (CVC), out of a total sample of 19 patients. Findings include: 1. The facility failed to ensure that RN #5 and CCHT #12 followed the manufacturers recommendations for use for Chloraprep while performing exit site care for Patient #18 and #13. Review of the facility procedure titled, CVC: Initiation and Discontinuation of Treatment, last revised 10/22/24, included the following: * Venous Catheter site must be inspected. Mask self, patient and anyone else observing or assisting. Review of the Manufacturer’s recommendations for the use of Chloraprep swabstick applicator included the following: * Completely wet the treatment area with the antiseptic, using gentle repeated back and forth strokes for 30 seconds. a. On 3/12/25 at 11:00 A.M., the surveyor observed RN #5 perform exit site care for Patient #18, who receives dialysis treatment through a CVC. She removed the old dressing covering the site and discarded it. She used a Chloraprep swabstick applicator in a gentle back and forth motion for 23 seconds, allowed it to dry and covered the site. She failed to disinfect the site for 30 seconds per the manufacturers recommendations for use. During an interview on 3/12/25 at 11:15 A.M., RN #5 said she should have disinfected the site with Chloraprep for 30 seconds, but forgot to look at the clock to time it. b. On 3/11/25 at 11:15 A.M., the surveyor observed CCHT #12 perform exit site care for Patient #13, who receives treatment via a CVC. CCHT #12 removed the old dressing covering the site and discarded it. CCHT #12 used two Chloraprep swabsticks, one at a time, for a total of 20 seconds. She failed to disinfect the area for a minimum of 30 seconds, per manufacturers recommendations for use. During an interview on 3/11/25 at 11:25 A.M., CCHT #12 said she cleaned the exit site for 1 minute, but was unable to see the clock on the wall. She further said that she uses the digital clock on the dialysis machine, but as she and the surveyor looked at the clock it only indicated time in hours/minutes, not seconds. 2. The facility failed to ensure that CCHT #7 did not use a contaminated cap to cover the CVC limbs during termination of treatment and failed to ensure that CCHT #7 encouraged Patient #4 to wear a mask covering his/her nose and mouth during termination of treatment. a. On 3/12/25 at 9:30 A.M., the surveyor observed CCHT #7 terminate treatment for Patient #17. CCHT #7 removed the dialysis machine line from the arterial limb of Patient #17’s CVC and scrubbed the hub of the catheter with an alcohol prep pad. She then attached a syringe of normal saline and flushed the limb. She proceeded to take the cover off of a sterile cap, she put the cap in the palm of her right hand, closing her hand around the cap, contaminating the cap, she then opened an alcohol prep pad and scrubbed the hub of the arterial limb and applied the contaminated cap. She repeated the same process with the venous limb. During an interview on 3/12/25 at 9:40 A.M., CCHT #7 said she should not use contaminated supplies and would have to think of another way to hold the cap so it does not become contaminated during termination. 38141 b. On 3/11/25 at 2:40 P.M., during observations on the treatment floor, the surveyor observed CCHT #7 terminate the dialysis treatment for Patient #4, who had a CVC for dialysis access. Patient #4 wore a mask below his/her nose, only covering his/her mouth throughout the whole process of termination of dialysis treatment. CCHT #7 failed to encouraged Patient #4 to adjust his/her face mask to cover his/her nose and mouth while CCHT #7 performed termination of dialysis treatment with CVC, including disconnecting the blood lines. During an interview on 3/11/25 at 2:50 P.M., CCHT #7 said that she should have made sure that Patient #4’s mask was covering his/her nose and mouth. 10249”

“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: 38141 Based on record review, and staff interview, the facility failed to 1.) ensure that staff followed the prescription for the correct dialyzer (an artificial kidney/device used in hemodialysis to filter blood and remove waste and excess fluid when the kidneys are unable to perform this function adequately) for 1 of 4 prescriptions observed (Patient #15), and 2.) ensure staff delivered the dialysis treatment as prescribed, relative to Blood Flow Rate [BFR] (speed measured in millimeter per minute [ml/min] in which the patient’s blood is pushed through the dialysate and back into the body) for 1 of 4 prescriptions observed (Patient #16); and for 1 of 10 applicable patient’s (#4) records reviewed, out of a total sample of 19 patients. Findings include: 1. For Patient #15, the facility failed to ensure staff followed the prescription and used the prescribed dialyzer (an artificial kidney/device used in hemodialysis to filter blood and remove waste and excess fluid when the kidneys are unable to perform this function adequately). Patient #15 was admitted to the facility in October 2020, with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatment three times a week. Review of the physician’s treatment orders for Patient #15, dated 2/8/25, indicated the following: Dialyzer: Elisio 1.9 M On 3/11/25 at 10:05 A.M., during observations on the treatment floor, the surveyor reviewed the dialysis prescription for Patient #15 with Certified Clinical Hemodialysis Technician (CCHT) #3. Upon observation of the dialysis machine, the patient was using Elisio 1.7 dialyzer, not Elisio 1.9 dialyzer as ordered. During an interview on 3/11/25 at 10:10 A.M., CCHT #3 said he made a mistake, he said that Patient #15 should be on Elisio 1.9 dialyzer and that he will notify the physician. 2. For Patient #16 and #4, the facility failed to ensure that the dialysis prescription was delivered as prescribed relative to BFR. a. Patient #16 was admitted to the facility in February 2024, with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatment three times a week. Review of the physician’s treatment orders for Patient #16, dated 2/8/25, indicated the blood flow rate should run at 400 ml/min. On 3/11/25 at 2:05 P.M., during observations on the treatment floor, the surveyor reviewed the dialysis prescription for Patient #16 with RN #6. The surveyor observed Patient #16 receiving dialysis treatment and dialysis machine was set to a blood flow rate of 450 ml/min, not 400 ml/min as ordered. During an interview on 3/11/25 at 2:12 P.M., RN #6 reviewed the physician’s order and said that BFR should be running at 400 ml/min and not at 450 ml/min. 44223 b. Patient #4 was admitted to the facility in 12/2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 12/11/24, indicated the dialysis order included a BFR to be delivered at a rate of 350 ml/min. Review of 9 hemodialysis flowsheets, dated 1/30/25-3/5/25, indicated the BFR had not been delivered as prescribed for 3 of 9 treatments, including the following: *2/10/25 - The BFR was delivered at a rate of 300 ml/min, not the 350 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *2/12/25 - The BFR was delivered at a rate of 300 ml/min, not the 350 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *3/3/25 - The BFR was delivered at a rate of 250-300 ml/min, not the 350 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 3/12/25 at 2:50 A.M., the Clinic Manager said the expectation is that staff documents on the treatment sheets why there was a change in the BFR.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 3 staff members (Certified Clinical Hemodialysis Technician [CCHT] #1, CCHT #5, and CCHT #11) evaluated a vascular access to ensure functionality by the way of listening for a bruit the length of the access (swooshing sound heard with a stethoscope place over the access) for 2 of 4 applicable patients (#11 and #8) with arteriovenous fistula/graft (AVF/G) access sites, out of a total sample of 19 patients. Findings include: Review of the facility procedure titled, AVF-AVG Cannulation, Treatment Initiation and Termination, last revised 6/20/24, included the following: * The access is palpated for thrill and auscultated for bruit. Access is assessed for signs of infection, open sores, edema, and any potential problems for needle cannulation. Once the assessment is completed and patency is confirmed, cannulation sites are identified. Needles are NOT placed in an access that is clotted or suspected of being clotted. 1. On 3/11/25 at 11:00 A.M., the surveyor observed CCHT #1 initiate treatment for Patient #11, with an AVF, in station 18. CCHT #1 palpated the vascular access with her fingertips for the presence of thrill, disinfected the fistula sites, applied the tourniquet, and without assessing for the presence of a bruit she inserted the needle into the lower access and then the upper access site. The upper cannulation was not successful and CCHT #1 requested assistance from another staff member. During an interview on 3/11/25 at 12:40 P.M., CCHT #1 said that she should have listened to the access before cannulating. 2. On 3/11/25 at 11:25 A.M., after an unsuccessful cannulation attempt by CCHT #1, the surveyor observed CCHT #5 assist with initiation of treatment for Patient #11, with an AVF, in station 18. CCHT #5 palpated the vascular access with her fingertips for the presence of thrill, disinfected the fistula sites, applied the tourniquet, and inserted the needle into the upper access. CCHT #5 did not assess Patient #11’s AVF access for the presence of bruit. During an interview on 3/11/25 at 12:35 P.M., CCHT #5 said that because there was a needle in the lower access she assumed CCHT #1 had listened for the bruit. 10249 3. On 3/11/25 at 11:15 A.M., the surveyor observed CCHT #11 initiate treatment for Patient #8, with an AVG, in station 39. CCHT #11 palpated the vascular access with her fingertips for the presence of thrill, disinfected the fistula sites, and inserted the needle into the lower access and then the upper access. CCHT #11 did not assess Patient #8’s AVG access for the presence of bruit. During an interview on 3/11/25 at 11:35 A.M., CCHT #11 said she did not use a stethoscope to listen, but instead felt the area with her fingers.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 10249 Based on review of the facility’s Infection Control Visual Audits, observations, staff interviews, and policy review, the facility failed to 1.) bring forth the visual audit results to monthly QAPI meetings to ensure they could be consistently tracked, measured, and analyzed, and 2.) ensure actions plans were developed to resolve identified infection control concerns. Findings include: Review of the facility policy titled, Quality Assessment and Performance Improvement (QAPI), Last revised 1/13/25, included the following, but not limited to: *The QAPI program must: *Continually look at the indicators for patients and associates as they are available. *Trend outcomes. *Identify any commonalities among patients who do not reach minimum expected outcomes. *Develop an improvement plan when indicated by the data. *Implement an action plan. *Adjust portions of the plan to achieve success. *Review in-center hemodialysis and home program separately. At a minimum, the QAPI program must include: *Infection control. *QAPI indicators must be monitored monthly. Continuous monitoring means that outcome data, adverse events infections, falls, errors, etc are monitored as this data is available or as these events occur. This process is facilitated by documentation and reviewing the indicators on a monthly basis using a QAPI reporting application. *Infection Control portion of the QAPI program must: *Analyze and document incidence of infection to establish baseline incidences and identify trends. *Develop recommendations and action plans to minimize transmission and promote immunization for both the patients and associates. *Take action to reduce future incidents. During the survey, 3/11/25 through 3/12/25, the surveyors observed several infection control breaches including: *Two staff failed to implement adequate hand hygiene and glove use while caring for patients and touching dialysis equipment. *Two staff failed to wear appropriate PPE during the initiation of treatment for 2 patients with an Arteriovenous fistula (AVF), and for 1 patient with a Central Venous Catheter (CVC). *Two staff failed to maintain separation of clean and dirty on the treatment floor. *Two staff failed to adequately disinfect the dialysis station and ensure that a bleach container remained closed to ensure efficacy. *Facility failed to ensure timely administration of a Hepatitis B vaccine series for 1 susceptible patient. *Three staff failed to adequately disinfect the cannulation site prior to initiation of treatment for 3 patients with AVF/G. *Two staff implemented adequate infection control measures during exit cite care, and 1 staff failed to ensure that a patient with a CVC was wearing a mask during the termination of treatment. Review of the facility’s Infection Control visual audits, dated 9/9/24 through 2/12/25, indicated the following: *September 9, 2024-Cleaning and Disinfection of the Dialysis Station. The Auditor identified 2 of 5 staff members failed to clean the Hanson connector and 3 of 5 staff failed to clean the counter /walls. *October 16, 2024-Initiation and termination with AVF/AVG. The auditor identified that policy and procedures (P&P) were reviewed for “Paws Pad use”, and glove use and hand hygiene. *November 20, 2024-Initiation, exit site care, and termination of dialysis with a CVC. The auditor identified the P&P was reviewed with 3 of 5 staff for glove removal and hand hygiene. *December 20, 2024-General Ph and Home Center observations, med preparation and treatment flash tour. Auditor identify the P&P was reviewed with staff around medication mix using proper sterile procedures. *January 29, 2025-Cleaning and Disinfection of Dialysis station. Auditor identified P&P was reviewed with staff around cleaning the counter /walls. *February 12, 2025-General Ph and Home Center observations, med preparation and treatment flash tour. No identified concerns by Auditor. There was no evidence that the results of the visual audits were documented during QAPI to assist in tracking and trending infection control concerns and establishing baseline information. There was no evidence that action plans were developed for any identified concerns. During an interview on 3/12/25 at 1:00 P.M., The Clinic Manager (CM) said she conducts monthly visual audits and shares the results with the Medical Director at the monthly QAPI meet. The CM said she does not document the results of the audits, nor which staff members were observed during the audits in the QAPI software, and was unable to identify treads in infection control breaches.”

“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: 10249 Based on observation, interview, and policy review, the Medical Director failed to 1.) ensure that 1 of 4 staff members (Certified Clinical Hemodialysis Technician [CCHT] #11 observed, administering heparin (a blood thinner used to minimize blood loss due to clotting of the dialysis system during treatment), adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment; 2.) ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration to initiate treatment for 1 of 6 applicable patients (#3) records reviewed, out of a total sample of 19 patients. Findings Include: Review of the policy titled, AV Fistula or Graft Cannulation, Treatment Initiation and Termination, lasted revised 6/20/24, indicated the following: *If ordered, administer the Heparin bolus as prescribed to the patients via the venous needle. Allow the heparin to circulate systemically for 3-5 minutes before initiating the hemodialysis treatment. Using the attached syringe, blood may be pushed/pulled thru the venous needle after the heparin is administered, to ensure all heparin is delivered to the systemic circulation. 1. For Patient #8, the Medical Director failed to ensure CCHT #11 adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Review of the clinical record indicated that Patient #8 had a physician’s order to administer heparin bolus 4000 units, every dialysis treatment. On 3/11/25 at 11:15 A.M., the surveyor observed CCHT #11 initiate treatment to Patient #8 through a arteriovenous graft (AVG). CCHT #11 was observed administering the heparin bolus at 11:30 A.M., then initiated treatment at 11:32 A.M., and did not wait the 3-5 minutes per facility policy. During an interview on 3/11/25 at 11:35 A.M., CCHT #11 said you are supposed to wait 5 minutes before starting the treatment. 31240 2. For Patient #3, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration to initiate treatment. Patient #3 was admitted to the facility in December 2019 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the clinical record indicated that Patient #3 had a physician’s order to administer a heparin bolus of 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 2/19/25 through 3/10/25, indicated for 5 of 9 treatments, staff failed to wait 3-5 minutes after administration of the heparin to initiate treatment including the following: *On 2/19/25 treatment started at 6:31 A.M., heparin was documented as administered at 6:37 A.M., 6 minutes after initiation of treatment, not the 3-5 minutes prior initiation of dialysis, per the facility policy. *On 2/21/25 treatment started at 6:46 A.M., heparin was documented as administered at 6:49 A.M., 3 minutes after initiation of treatment, not the 3-5 minutes prior initiation of dialysis, per the facility policy. *On 2/28/25 treatment started at 6:37 A.M., heparin was documented as administered at 7:13 A.M., 33 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 3/5/25 treatment started at 6:40 A.M., heparin was documented as administered at 6:47 A.M., 7 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 3/7/25 treatment started at 6:42 A.M., heparin was documented as administered at 6:48 A.M., 6 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. During an interview on 3/12/25 at 11:50 A.M., the Clinical Regulatory Manager said staff did not wait the 3-5 minutes to initiate treatment, after administering the heparin bolus, for the 5 treatment sessions noted above. She said the staff did not follow the facility policy as required.”