Fresenius Medical Care Chelmsford

“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: 10249 Based on observation, interview, and policy review, the facility failed to ensure there was a separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to ensure that proper infection control practices were followed when personal protective equipment (PPE) came in contact with both clean and dirty areas on the dialysis treatment floor. Findings include: During an initial observation of the treatment floor on 7/23/25 at 11:10 A.M., the surveyor observed a coat rack, located outside the medication preparation area. The coat rack had 3 gowns, 2 face shields, and 2 stethoscopes. The gowns, shields, and stethoscopes were all touching each other, causing a concern for potential cross contamination. During an interview on 7/23/25 at 11:30 A.M., the clinic Manager said that the PPE should not be touching, and she would look into it.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 31240 Based on observations, record reviews, staff interviews, document review, and policy reviews, the facility failed to ensure that the condition of infection control was met. Eight (8) of 10 facility staff observed, (Registered Nurse [RN] #3, RN #4, RN #7 and RN #8, Patient Care Technician [PCT] 1, PCT #2, PCT #6 and PCT #7) failed to perform adequate infection control measures to ensure the health and safety of all patients. Findings include: 1. The facility failed to ensure PCT #2 implemented adequate infection control practices related to glove use and hand hygiene while caring for a patient with a central venous catheter (CVC), to reduce the risk of spread of infection. Refer to V113. 2. The facility failed to ensure that 2 staff members (PCT #1 and PCT #7) wore a fluid resistant gown appropriately to protect from spurting or splatter of blood, increasing the risk of cross contamination. Refer to V115. 3. The facility failed to ensure 2 of 2 staff members (PCT #6 and RN #7) observed, adequately disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens. Refer to V122. 4. The facility failed to ensure that 1 of 2 staff members (PCT #7), implemented adequate infection control practices during 1 of 2 observations of initiation of dialysis treatment for a patient with an arteriovenous fistula or graft (AVF/AVG), to reduce the risk of infection. Refer to V142. 5. The facility failed to ensure that 2 of 3 staff members (RN #8 and RN #4) implemented aseptic technique when preparing medication for intravenous [IV] administration. Refer to V143. 6. The facility failed to ensure that 1 of 2 staff (RN #3) observed adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable patients (#11), with a central venous catheter (CVC), out of a total sample of 11 patients. Refer to V147.”

“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 1 staff member (Patient Care Technician [PCT] #2) implemented adequate infection control practices related to glove use and hand hygiene while caring for a patient with a central venous catheter (CVC), to reduce the risk of spread of infection. Findings include: Review of the facility policy, titled, Personal Protective Equipment, published 11/6/23, included the following: * Staff must remove gloves and wash hands after: patient care, exposure to blood and body fluids, touching any surfaces within the patient station. On 6/10/25 at 10:50 A.M., the surveyor observed PCT #2 discontinuing dialysis treatment for a patient in station #8 who had a CVC. After flushing the arterial line, PCT #2 dropped an empty syringe on the floor next to the sharps container in the station. With her gloved hand, she picked the syringe up off the floor and discarded it in the sharps container. Without removing her gloves and washing her hands she proceeded to disconnect the patient’s venous line from the machine. During an interview on 6/10/25 at 11:40 A.M., PCT #2 said she should have changed her gloves after she picked up the syringe off the floor.”

“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 (Patient Care Technician [PCT] #1 and PCT #7) wore a fluid resistant gown appropriately to protect from spurting or splatter of blood, increasing the risk of cross contamination. Findings include: Review of the facility policy, titled, Personal Protective Equipment, published 11/6/24, included the following: * Personal protective equipment (PPE) including a full-face shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employee from blood or other potentially infectious materials (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or splattering of blood might occur (e.g. during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). 1. On 6/10/25 at 9:55 A.M., the surveyor observed PCT #1 initiate dialysis treatment for a patient with an arteriovenous graft (AVG), in station #18. During the procedure the sleeves of PCT #1’s gown were pushed up her arms exposing both wrists, including a blue band. During an interview on 6/11/25 at 8:30 A.M., the Clinic Manager (CM) said that gowns should be worn so there is no exposed skin or jewelry during the initiation or discontinuation of dialysis treatment. 2. On 6/10/25 at 11:30 A.M., the surveyor observed PCT #7 disconnect a patient with an arteriovenous fistula or graft (AVF/G) from dialysis treatment in station #3. During the procedure the sleeves of PCT #7’s gown were pushed up her arms exposing both wrists, including a watch and black band. On 6/10/25 at 11:45 A.M., the surveyor observed PCT #7 initiate dialysis treatment for a patient with an arteriovenous fistula (AVF) in station #2. During the procedure the right sleeve of PCT #7’s gown was pushed up her arm exposing a black band. During an interview on 6/10/25 at 12:05 P.M., PCT #7 said she thought she had pushed the sleeves of her gown down to cover her wrists. During an interview on 6/11/25 at 8:30 A.M., the Clinic Manager (CM) said that gowns should be worn so there is no exposed skin or jewelry during the initiation or discontinuation of dialysis treatment.”

“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: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure 2 of 2 staff members (Patient Care Technician [PCT] #6 and Registered Nurse [RN] #7) observed, adequately disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens. Findings Include: Review of the facility policy, entitled Cleaning and Disinfecting the Dialysis Station, published 9/5/23, indicated the following: Definition: Dialysis Station *Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: -Dialysis machine/cycler and attachments such as IV pole, BP cuff and hand sanitizer/holder, organizer -chair/bed -Pureflow SL -Individual television and remote *All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glisteningly wet and let air dry unless otherwise specified by the manufacturer. 1. On 6/10/25 at 9:55 A.M., the surveyor observed PCT #6 disinfect station #1 for the next patient. She was observed to disinfect the hemodialysis machine and the hemodialysis chair using 1:100 bleach soaked pads. PCT #6 failed to disinfect underneath the tray tables on both sides of the chair. During an interview on 6/10/25 at 10:05 A.M., PCT #6 said she should have cleaned all areas of the chair including underneath the tray tables. 27189 2. On 6/11/25 at 10:10 A.M., the surveyor observed Registered Nurse (RN) #7 disinfecting station #12 to prepare the treatment area and dialysis machine for the next patient. She disinfected all of the areas and dialysis machine using disposable wipes that were soaked with a 1:1000 bleach solution except for the following: *The counter top behind the dialysis machine. *The top of of the Intravenous (IV) pole and the four extensions at the top of the IV pole. *The basket on the side of the dialysis machine (blood pressure cuffs are stored there). During an interview on 6/11/25 at 10:24 A.M., RN #7 said all of the above areas should have been disinfected, but were not, during the process, as required.”

“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 that 1 of 2 staff members (Personal Care Technician [PCT] #7, implemented adequate infection control practices during 1 of 2 observations of initiation of dialysis treatment for a patient with an arteriovenous fistula or graft (AVF/AVG), to reduce the risk of infection. Findings include: Review of the facility policy, titled, Access Assessment and Cannulation, published 5/5/25, included the following: * Prior to treatment, ask patient to wash access area with soap and water, per hand hygiene procedure. If the patient is unable to wash their own access, the staff or care partner should wear gloves to wash the patient’s access with soap and water. If unable to wash with soap and water, staff may use hand sanitizer with 60-70% alcohol to clean access arm in place of soap and water. * Disinfect cannulation site using 70% isopropyl alcohol pad: using gentle friction clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating. On 6/10/25 at 11:45 A.M., the surveyor observed PCT #7 escort Patient #9 from the waiting room to the treatment floor. PCT #7 went to station 2 while Patient #9 went to the sink and washed his/her hands, but not the access site, and then proceeded to station 2. PCT #7 assessed the access and without washing the access began to disinfect the lower cannulation site with an alcohol prep pad for 10 seconds, not 30 seconds per the policy. She taped the needle in place and proceeded to disinfect the upper cannulation site for 10 seconds, not 30 seconds per the policy. She taped the needle in place and proceeded to initiate dialysis treatment. During an interview on 6/10/25 at 12:05 P.M., PCT #7 said the access site should be washed by the patient or staff before disinfecting. She said she thought the patient had washed his/her access site when they went to the sink. She also said cannulation sites should be disinfected for 20 seconds prior to cannulation. She said she had counted to 20, but must have counted too fast, next time she will use the clock.”

“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: 37349 Based on observation, interview and policy review, the facility failed to ensure that 2 of 3 staff members (Registered Nurse [RN] #8 and RN #4) implemented aseptic technique when preparing medication for intravenous [IV] administration. Findings include: Review of the facility policy, titled, Medication Preparation and Administration, published 2/6/23, included the following: * Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol. On 6/10/25 at 10:35 A.M., the surveyor observed RN #8 prepare an IV antibiotic for administration. She removed caps from two vials of an antibiotic and 1 vial of sterile water. She proceeded to use an alcohol prep pad to disinfect the diaphragm of antibiotic vial #1. She used a new alcohol prep pad to disinfect the diaphragm of antibiotic vial #2 and another new alcohol prep pad to disinfect the diaphragm of the sterile water. She used a needle to access the sterile water, withdrew 10 milliliters of sterile water, removed the needle from the sterile water vial and instilled it into antibiotic vial #1. Without disinfecting the diaphragm of the sterile water, she proceeded to use a new needle to access the sterile water and repeated the procedure for the antibiotic vial #2. She used an alcohol prep pad and cleansed the diaphragm of antibiotic vial #1 and a new alcohol prep pad to cleanse the diaphragm of antibiotic vial #2. She proceeded to use a new alcohol prep pad and cleansed the diaphragm of a bag of normal saline. She used a new needle and removed the antibiotic from vial #1 and instilled it into the saline bag. Without cleansing the diaphragm of the saline bag port, she proceeded to use a new needle to remove the antibiotic from vial #2 and instill it into the normal saline port. Once completed she administered the antibiotic to a patient in station 4. During an interview on 6/10/25 at 10:50 A.M., RN #8 said the diaphragm of the vial and port should have been cleansed with alcohol each time it was accessed. 27189 2. On 6/11/25 at 8:40 A.M., the surveyor observed RN #4 prepare two syringes for mid-treatment heparin boluses for two different patients. She removed the multi-dose vial of heparin 30,000 units/30 milliliter (ml’s) from the medication draw along with 2 syringes. She disinfected the rubber diaphragm with an alcohol wipe and withdrew the first dose of heparin 1 ml (1000 units), capped and labeled the syringe. Without disinfecting the rubber diaphragm, she withdrew the second dose of heparin 1,000 units, capped and labeled the second syringe. RN #4 failed to disinfect the rubber diaphragm prior to preparing the second dose. During an interview on 6/11/25 at 9:03 A.M., RN #4 said she did not disinfect the rubber diaphragm of the multi-dose vial prior to accessing the vial for the second dose of heparin.”

“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: 44223 Based on observations, interviews, and policy review, the facility failed to ensure that 1 of 2 staff (Registered Nurse [RN] #3) observed adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable Patients (#11), with a central venous catheter (CVC), out of a total sample of 11 patients. Findings Include: Review of the facility policy, titled Changing the Catheter Dressing Procedure, published 5/2/25, indicated the following: *Apply mask to patient and caregiver to help prevent contamination by airborne nasal bacteria. For Patient #11, the facility failed to ensure that RN #3 observed adequate infection control practices to minimize the risk of infection during exit site care. On 6/10/25 at 10:30 A.M., during an observation on the treatment floor, the surveyor observed RN #3 in station 13 initiate exit site care for Patient #11. RN #3 failed to cover her nose with her mask during the disinfection of the area around the catheter and during the initiation of treatment. During an interview on 6/10/25 at 10:55 A.M., RN #3 said she should have made sure her mask was covering both her nose and mouth. She said she did not even realize that the mask was below her nose.”

“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: 31240 Based on record review, policy review and interview, the facility failed to ensure staff conducted Pre-dialysis Nursing Assessments within one hour of the initiation of dialysis treatment for 1 patient (#4) of 7 applicable patients reviewed, out of a total sample of 11 patients. Findings include: Review of the facility policy entitled, Nursing Supervision and Delegation, dated 11/6/23, indicated the following: Policy: The registered nurse (RN) must evaluate each patient preferably within an hour or according to state regulations to: *Confirm identity. *Review the patient’s condition. *Review accuracy and completeness of treatment and patient data. *Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. *Confirm that the correct vascular access is being used, and that the access is visible. *Observe patient’s response to treatment. *Verify machine safety checks have been completed. *Talk to the patient to elicit information such as changes in condition, response to treatment, new injuries, information/education needs or complaints, and satisfaction with care. Patient #4 was admitted to the facility in March 2025 with a diagnosis of End Stage Renal Disease, requiring hemodialysis treatment 3 times a week. Review of 9 treatment sheets, dated 5/21/25 through 6/9/25, indicated for 3 of 9 treatments, the nursing assessment was not completed within the first hour of dialysis treatment including the following: *On 5/21/25, the patient’s dialysis treatment began at 1:57 P.M., the nursing assessment was not completed until 4:43 P.M., exceeding the one hour requirement. *On 6/2/25, the patient’s dialysis treatment began at 1:55 P.M., the nursing assessment was not completed until 3:38 P.M., exceeding the one hour requirement. *On 6/9/25, the patient’s dialysis treatment began at 1:53 P.M., the nursing assessment was not completed until 3:00 P.M., exceeding the one hour requirement. During an interview on 6/11/25 at 2:25 P.M., the Clinical Manager said nursing staff are required to complete and document the patient’s assessment within the first hour of treatment. She said the 3 assessments were late and not completed timely, as required.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 37349 Based on record review and staff interview, the facility failed to ensure that the Interdisciplinary Team (IDT) developed and implemented a written, individualized plan of care (POC) for each patient that included services necessary to address patients’ needs and changes in patients’ condition, measurable and expected outcomes, and estimated timetables to achieve these outcomes in regard to dialysis access for 4 of 7 applicable Patients (#2, #7, #5, and #1) with a Central Venous Catheter (CVC), out of a total sample of 11 patients. Findings include: Review of the facility policy, titled Comprehensive Interdisciplinary Assessment and Plan of Care, published 7/3/23, indicated the following: *The patient plan of care will be developed from the findings gathered in the CIA. The IDT members are expected to interact and share information from the comprehensive assessment to facilitate the development of the plan of care. 1. For Patient #2, the facility failed to ensure the patient had a complete and individualized plan of care that included estimated timetables and measurable goals regarding preventing dialysis access infections. Patient #2 was admitted to the facility in October 2021 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis, and received dialysis through a CVC. Review of the treatment flow sheet for 6/2/25 indicated that staff observed the CVC exit site dressing to be soiled or wet with pus. The corresponding Multidisciplinary note for 6/2/25 indicated that the CVC exit site had brown drainage, no fever, no pain. Doctor aware, order for wound and blood culture times two and an intravenous (IV) antibiotic for 3 doses. Further review of the treatment sheets indicate that Patient #2 received the IV antibiotic on 6/2/25, 6/4/25 and 6/6/25. Review of the current Plan of Care, dated 3/20/25, included a problem of “Dialysis Access” that was created on 2/10/24 with a goal for no catheter and a note that Patient #2 had opted out on having a permanent vascular access. Interventions included If CVC present refer to vascular access plan. If CVC present and patient refuses referral, review access plan with each plan of care conference. Patient signed the refusal form. The Plan of Care failed to include a goal or interventions to remain infection free while utilizing the CVC. Review of the The Informed Consent for Refusal to Discontinue use of Hemodialysis CVC, dated 2/12/25, 11/18/24, 7/3/24, 4/12/24 and 1/15/24 indicated that Patient #2 was informed of the risk of serious infection related to CVC use, but failed to include care of the CVC to reduce the risk of infection. During an interview on 6/11/25 at 8:45 A.M., the Clinical Manager said that patients with a CVC should have a plan of care with a goal and intervention to remain infection free. 44223 2. For Patient #7, the facility failed to ensure the patient had a complete and individualized plan of care that included estimated timetables and measurable goals regarding preventing dialysis access infections. Patient #7 was admitted to the facility in May 2023 with a diagnosis of ESRD, requiring hemodialysis, and received dialysis through a CVC. Review of the current Plan of Care, dated 1/31/25, included a problem of “Dialysis Access” that was created on 1/23/25 with a goal for no catheter and vascular consult. Interventions included to educate the patient on benefits and risks of access types, to educate patient on the care of access, and to review access plan with each plan of care conference. The Plan of Care failed to include a goal or intervention to remain infection free while utilizing the CVC. During an interview on 6/11/25 at 8:45 A.M., the Clinical Manager said that patients with a CVC should have a plan of care with a goal and intervention to remain infection free. 31240 3. For Patient #5, the facility failed to ensure the patient had a complete and individualized plan of care that included estimated timetables and measurable goals regarding preventing dialysis access infections. Patient #5 was admitted to the facility in April 2022 with a diagnosis of ESRD requiring hemodialysis 3 times a week through a CVC. Review of the annual Plan of Care (POC), dated 10/22/24, included a focus area titled, “Dialysis Adequacy Access”. The section indicated to monitor patency of the CVC. The POC failed to include a goal or interventions for the care of CVC and to remain infection free while utilizing the CVC. During an interview on 6/10/25 at 3:15 P.M., the Clinical Director said that if a patient has a CVC, their POC should include interventions and goals related to the care, monitoring, minimization of the risk of infection of CVC during dialysis. She said Patient # 5’s POC did not include these. 27189 4. For Patient #1, the facility failed to ensure Patient #1 had a complete and individualized POC that included a goal and/or interventions related to preventing a dialysis access (CVC) infection. Patient #1 was admitted to the facility in May 2023 with a diagnosis of ESRD, requiring hemodialysis. Patient #1 had a CVC in place for dialysis access. Review of the POC, dated 5/23/25, was as follows: **Area of Focus - Dialysis Access. **Goal - No catheter. **Interventions: *Educate patient/family/caregiver on benefits and risks of access types. *Educate patient/family/caregiver on the care of access. *Educate quarterly on importance of permanent access placement. The POC failed to include a goal and/or interventions to remain infection free while utilizing the CVC for dialysis access. During an interview on 6/11/25 at 4:00 P.M., the Clinical Manager said that was no goal and/or intervention related to remaining infection free while the CVC was being utilized.”

“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: 37349 Based on observation, record review, and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer and back into the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min) to draw toxins from the patient’s blood during the process of dialysis for 2 patients observed (#8 and #9) and 2 patient records reviewed (#5 and #7), out of a total sample of 11 patients. Findings include: 1. Patient #8 was admitted to the facility in August 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician’s orders, dated 6/10/25, indicated the BFR was to be delivered at a rate of 300 ml/min. On 6/10/25 at 9:15 A.M., the surveyor and Patient Care Technician (PCT) #2 observed the dialysis machine BFR running at 350, not 300 as ordered. During an interview on 6/10/25 at 9:15 A.M., PCT #2 said the dialysis machine had not been set to the prescribed BFR and she needed to lower the rate to 300 per the physician order. During an interview on 6/11/25 at 8:05 A.M., the Clinic Manager said that staff should follow the physician order. 2. Patient #9 was admitted to the facility in April 2025 with a diagnosis of ESRD, requiring hemodialysis treatment 3 times per week. Review of the physician’s orders, dated 5/31/25, indicated the BFR was to be delivered at a rate of 400 ml/min. On 6/10/25 at 12:00 P.M., the surveyor observed PCT #7 initiate dialysis treatment for Patient #9. After initiation the surveyor and PCT #7 observed the dialysis machine BFR running at 450, not 400 as ordered. During an interview on 6/10/25 at 12:05 P.M., PCT #7 said Patient #7 uses 15 gauge needles and she usually sets the BFR to 450 when 15 gauge needles are used. She said she would clarify with the nurse. During an interview on 6/11/25 at 8:05 A.M., the Clinic Manager (CM) said that staff should follow the physician order. She said she spoke to PCT #7 to clarify that even though many patients using a 15 gauge needle are prescribed a BFR of 450, Patient #9 has an order for a BFR of 400. 44223 2. Patient #7 was admitted to the facility in May 2023 with a diagnosis of ESRD, requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 5/10/25 and 5/31/25 indicated the dialysis order included a BFR to be delivered at a rate of 400 ml/min and a DFR to be delivered at a rate of 500 ml/min and 800 ml/min. Review of 9 hemodialysis flow sheets, dated 5/10/25 through 5/31/25, indicated the BFR and DFR had not been delivered as prescribed for 4 of 9 treatments, including the following: *5/22/25-There was no documentation of the BFR/DFR rates on the treatment sheets. *5/24/25-There was no documentation of the BFR/DFR rates on the treatment sheets. *5/27/25-There was no documentation of the BFR/DFR rates on the treatment sheets. *6/7/25-The BFR was delivered at a rate of 325-380 ml/min, not the 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 6/11/25 at 8:45 A.M., the CM said the BFR/DFR should be documented on the treatment sheets. She said if the BFR/DFR is missing it is because staff did not transfer the information manually. The CM also said it is the expectation that if the BFR/DFR is changed that staff documents the reason why on the treatment sheet. 31240 4. Patient #5 was admitted to the facility in April 2022 with a diagnosis of ESRD, requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 4/7/25, indicated the dialysis order included a BFR to be delivered at a rate of 350 ml/min and a DFR to be delivered at a rate of 500 ml/min. A physician order, dated 5/31/25, indicated the dialysis order included a BFR to be delivered at a rate of 350 ml/min and a DFR to be delivered at a rate of 800 ml/min. Review of 9 hemodialysis flow sheets, dated 4/29/25 through 6/7/25, indicated the BFR and DFR had not been delivered as prescribed for 4 of 9 treatments, including the following: *4/29/25-The DFR was delivered at a rate of 800 ml/min, not 500 ml/min as ordered. There was no documentation to indicate why the physician’s order was not followed. *5/3/25-The BFR was delivered at a rate of 235 and 400 ml/min, not the 350 ml/min as ordered. There was no documentation to indicate why the physician’s order was not followed. *5/22/25-The BFR was delivered at a rate of 300, 320 and 400 ml/min, not the 350 ml/min as ordered. There was no documentation to indicate why the physician’s order was not followed.. *6/3/25-The BFR was delivered at a rate of 300 and 320 ml/min, not the 350 ml/min as ordered. There was no documentation to indicate why the physician’s order was not followed. During an interview on 6/11/25 at 10:40 A.M., the CM said that staff should be documenting on the treatment sheet when the BFR and DFR are not delivered as ordered by the physician. She staff did not follow the physician’s order for the treatment days noted above, and did not provide any documentation to indicated why.”

“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: 31240 Based on review of the facility Quality Assessment Performance Improvement (QAPI) committee meeting minutes, review of the monthly infection control audits, interview, and policy review, the facility failed to: (1) Ensure monthly visual infection control audits were completed for arteriovenous fistula and graft (AVF/AVG) disinfection compliance, and to ensure they could be consistently measured, analyzed, and a plan developed based on findings. (2) Analyze declining trends and implement corrective action plans based on the results of monthly Clinic Audit Checklists. Findings include: Review of the facility policy titled, Quality Assessment and Performance Improvement Program, dated 11/4/24, indicated the following: *The QAPI Committee will monitor data/information, prioritize areas for improvement, determine potential root cause analysis, develop, implement, evaluate and revise action plans that results in sustainable improvements in patients care. *Elements to be reviewed will include: -Patient care outcomes. -Infection surveillance. -Patient safety. -Staff training and education. *An effective and successful review of QAPI meeting and program activities will include: -Analysis of QAPI trending tool. -Review of the results of required self-audits. -Prioritizing identified opportunities for improvement. -Performing a Root Cause Analysis on the identified opportunities to include identification of commonalities, circumstances, conditions or barriers that are impacting quality improvement and facility indicators. *Following a Root Cause Analysis, action plans will be determined and prioritized by the QAPI Committee, considering the prevalence and severity of identified problems and by ranking those which have potential to affect patient health and safety as a higher priority than those do not have such potential. 1. During the survey, 1 of 2 staff members (Patient Care Technician [PCT] #7 observed had an infection control breach during the initiation of hemodialysis treatment for a patient with an AVF. PCT #7 failed to wash the access sites and failed to disinfect the cannulation sites for the required time frame, per the policy. Review of the facility’s Clinical Practice Checklist document, used for monthly auditing, did not include observation for the initiation and discontinuation of AVF/G. During an interview on 6/11/25 at 3:45 P.M., the Clinical Manager said the checklist should include observation of the initiation and discontinuation of AVF/G, to minimize the risk of infection and/or complications during dialysis treatment. 2. Review of Clinic Audit Checklists: Clinical Practices (included, but not limited to the following focus areas: hand hygiene, proper personal protective equipment use, intravenous medication prep, monitoring patients during treatment and disinfection of the station), dated 12/9/24 through 6/3/25, indicated the following scores: *December 2024 and January 2025=100% *February 2025=71.43% *March 2025=52.38% *April 2025=71.43% *May 2025=80.95% *June 2025=71.43% During the survey the following infection control concerns were observed: *Patient Care Technician (PCT) #2 failed to implement adequate infection control practices related to glove use and hand hygiene while caring for a patient, to reduce the risk of spread of infection. *PCT #1 and PCT #7 failed to wear fluid resistant gowns properly, to protect from spurting or splatter of blood, increasing the risk of cross contamination. *PCT #6 and Registered Nurse (RN) #7 failed to adequately disinfect contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens. *PCT #7 failed to implement adequate infection control practices during 1 of 2 observations of initiation of dialysis treatment for a patient with an arteriovenous fistula or graft (AVF/AVG) to reduce the risk of infection. *RN #8 and RN #4 failed to implement aseptic techniques when preparing medication for intravenous [IV] administration. *RN #3 failed to maintain adequate infection control practices to minimize the risk of infection during exit site care for 1 of 2 applicable patients, with a central venous catheter (CVC). During an interview on 6/11/25 at 8:40 A.M., the Medical Director was unaware of downward trends in the infection control audits but would work with Clinical Manager to improve the process and results. During an interview on 6/11/25 at 9:45 A.M., the Clinical Manager (CM) said the Clinical Practice Checklist used for monthly auditing included reviews of infection practices during and after dialysis, personal protective equipment (PPE), medication preparation and administration, supplies and equipment, and the water testing and water room environment. During an interview on 6/11/25 at 2:30 P.M., the CM said the current process was not effective as the results have shown a decline since January 2025. The CM and the Director of Operations said there had not been an analysis of the decline and there had not been an action plan implemented to improve the results of the monthly audits. .”

“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: 27189 Based on observation, policy review and interview, the Medical Director failed to ensure that staff adhered to the heparin administration policy for the mid-treatment administration of heparin (blood thinning medication) for 1 patient (#10) in a total sample of 11 patients. Findings include: Review of the facility policy titled Heparinization, dated 9/2/24, indicated but was not limited to the following: *Heparin bolus (during treatment) is given intravenous (IV) push via the arterial line/saline line luer-lock med port. . 1. For Patient #10, the facility failed to ensure that the mid-treatment heparin bolus was administered through the arterial line port. On 6/11/25 at 8:50 A.M., Registered Nurse(RN) #4 was observed administering a mid-treatment bolus of heparin. Prior to administration, RN #4 and the surveyor verified the physician’s orders. The current physician’s order indicated the patient was to receive a bolus of 1,000 units of heparin mid-treatment. RN #4 then administered the bolus of heparin through the venous line luer-lock port. The surveyor then verified which port the heparin bolus was administered through and RN #4 said the venous port. During an interview on 6/11/25 at 11:45 A.M., RN #4 said that she had administered the mid-treatment heparin bolus through the venous line luer-lock port and not through the arterial line luer-lock port as per the facility policy for mid-treatment heparin administration.”