Fresenius Kidney Care Slinger

“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: 29972 Based on record review, observation, and interview staff failed to perform hand hygiene before donning gloves, after removing gloves, between glove changes, and before obtaining clean supplies and medication in 5 of 12 patient care observations (Patient (Pt) #5, 8, 10, 12, 13), in a total sample of 12 patients observed; and failed to perform hand hygiene after removing gloves while cleaning and disinfecting the dialysis station in 1 of 2 observations of station cleaning (Station (St) 9), in a total of 2 observations of station cleaning. Findings Include: Review of policy and procedure #47664 titled, “Hand Hygiene” version 8 published 11/06/2023 revealed: - Hands will be “decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients...Before performing any invasive procedure such as vascular access cannulation or administration of parenteral (intravenous--IV) medications...Immediately after removing gloves...When moving from a contaminated body site to a clean body site of the same patient.” - “Apply alcohol-based hand rub to the palm of one hand...Rub hands together covering all surfaces of the hands and fingers, until hands are dry...” On 09/25/2024 beginning at 10:00 AM, observed Dialysis Technician (DT) F initiating Pt #5’s dialysis treatment using a Central Venous Catheter (CVC). Observed DT F perform Pt #5’s CVC dressing change; DT F removed Pt #5’s old CVC dressing, then removed gloves and donned a new pair of gloves without performing hand hygiene between glove changes. Observed DT F collect labs from Pt #5’s CVC line, remove gloves, and obtain a Heparin syringe from the “clean” medication counter; DT F did not perform hand hygiene after removing gloves and before accessing clean supplies. DT F proceeded to don gloves and administer IV Heparin via Pt #5’s CVC line without first performing hand hygiene. On 09/25/2024 beginning at 10:17 AM, observed DT F touch Pt #13’s dialysis machine at St 6 with a glove wrapped around DT F’s index finger; DT F disposed of the glove and did not perform hand hygiene. DT F then proceeded to touch Pt #5’s dialysis machine at St 7 with a glove wrapped around DT F’s index finger; DT F disposed of the glove and did not perform hand hygiene. On 09/25/2024 beginning at 10:25 AM, observed DT F discontinuing Pt #12 dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G). DT F removed gloves and kept the gloves in the palm of hand while attempting to apply hand sanitizer to hands; DT F was unable to sanitize all surfaces of the hands due to holding the gloves. On 09/25/2024 beginning at 10:37 AM, observed DT F cleaning and disinfecting St #9; after cleaning the station, DT F removed gloves and did not perform hand hygiene. On 09/25/2024 beginning at 11:00 AM, observed Registered Nurse (RN) D administering intravenous (IV) medications to Pt # 8. RN D donned gloves and performed Pt #8’s physical assessment; RN D then removed gloves, donned a new pair of gloves, and administered Pt #8’s IV medications without performing hand hygiene between glove changes. On 09/25/2024 beginning at 11:20 AM, observed DT I initiating Pt #10’s dialysis treatment using a AVF/G. DT I cannulated Pt #10’s vascular access sites, removed gloves, touched his/her face and glasses, and then proceeded to don a new pair of gloves; DT I did not perform hand hygiene after removing gloves and before donning a new pair of gloves. During interview with Director of Operations (DO) B and Clinical Manager (CM) C on 09/27/2024 beginning at 12:28 PM, while discussing observations, DO B and CM C stated that staff should be performing hand hygiene as per policy.”

“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: 29972 Based on observation, record review, and interview facility staff failed to wear personal protective equipment (PPE) appropriately when initiating dialysis treatment in 1 of 12 patient care observations (Patient (Pt) #5), in a total sample of 12 patient observations of care. Findings Include: Review of policy and procedure #47663 titled, “Personal Protective Equipment” version 6 Published 11/06/2023 revealed; - “Personal protective equipment including a full face-shield or mask and protective eyewear with full side shield...must be worn to protect employees from blood or other potentially infectious materials.” On 09/25/2024 beginning at 10:00 AM, observed Dialysis Technician (DT) F initiating Pt #5’s dialysis treatment using a Central Venous Catheter (CVC). DT F’s face-shield did not cover his/her mouth and DT F did not have on a mask during Pt #5’s dialysis treatment initiation. During interview with Director of Operations (DO) B and Clinical Manager (CM) C on 09/27/2024 beginning at 12:28 PM, while discussing observations, DO B and CM C stated that staff should wear a full face-shield and a mask while initiating dialysis treatment using a CVC.”

“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: 29972 Based on observation, record review, and interview staff failed to ensure patients vacate the dialysis station before staff clean and disinfect the station in 1 of 2 observations of dialysis station cleaning (Patient (Pt) #12), in a total sample of 2 observations of station cleaning; failed to clean and disinfect all the equipment at the dialysis station between patients to prevent cross contamination in 2 of 2 observations of dialysis station cleaning (St #9 and 12), in a total sample of 2 observations of station cleaning; and failed to clean and disinfect a used stethoscope before returning to a “clean” area in 1 of 4 observations of patient care assessments using a stethoscope (Patient (Pt) #12), in a total of 12 patient care observations. Findings Include: Review of policy and procedure #47806 titled, “Cleaning and Disinfecting the Dialysis Station” version 14 published 09/05/2023 revealed: - “A dialysis station must be cleaned and disinfected between dialysis patients.” - Dialysis Stations: “Area including the dialysis machine, chair, and other reusable equipment or supplies utilized during dialysis treatment...Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine and attachments such a IV (intravenous) pole, BP (blood pressure) cuff and hand sanitizer/holder...” - “To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station...” Review of policy and procedure #45178 titled, “Access Assessment and Cannulation” version 4 published 05-06-2024, revealed: - “Clean stethoscope after assessing a patient.” On 09/25/2024 beginning at 10:37 AM, observed Dialysis Technician (DT) F cleaning the dialysis machine at St 9 while Pt #12 remained in the chair holding his/her vascular access site to achieve hemostasis. On 09/25/2024 beginning at 10:37 AM, observed DT F cleaning and disinfecting St #9; DT F did not clean the following items at the dialysis station: - Inside of the Primewaste container - Bottle of hand sanitizer/holder - Biohazard container attached to the machine On 09/25/2024 beginning at 11:05 AM, observed Patient Care Technician (PCT) G cleaning and disinfecting St #12; PCT G did not clean all areas of the Biohazard container attached to the dialysis machine. On 09/25/2024 beginning at 10:25 AM, observed DT I using a stethoscope to assess Pt #12’s Arterivenous Fistula/graft. After using the stethoscope DT I placed the stethoscope on a “clean” countertop; DT I did not clean and disinfect the stethoscope before returning to a common area. During interview with Director of Operations (DO) B and Clinical Manager (CM) C on 09/27/2024 beginning at 12:28 PM, while discussing observations, DO B and CM C stated that staff should be cleaning the items identified between patients and stated that the stethoscope should be cleaned before returning to a “clean” area. DO B and CM S stated patients should be discharged and out of the chair before staff clean the station.”

“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: 29972 Based on observation, record review, and interview the facility staff failed to administer medications using aseptic technique in 2 of 2 observations of medication administration (Patient (Pt) #6 and #8), in a total sample of 12 observations of patient care. Findings Include: Review of policy and procedure titled, “Pre-Filled Saline Syringe Special Considerations” version 1 published 06/28/2017 revealed; - “ESRD (end stage renal disease) facilities may not fill syringes with saline from the single dose saline bag or extracorporeal bloodlines at the dialysis station. To comply with recommended safe injection practices, the facility may acquire pre-filled syringes for an individual patient and store them in a clean area away from the patient treatment area.” Review of the manufacturer guidelines box insert for 0.9% Sodium Chloride 1000 milliliter (ml) saline bags revealed, “The solution contains no bacteriostat (agent to prevent the growth of bacteria), antimicrobial agent or added buffer and is intended only as a single-dose injection.” On 09/25/2024 beginning at 11:55 AM, observed Registered Nurse (RN) D administering intravenous (IV) medication to Pt #8 during dialysis treatment. RN D connected a needle to a syringe and inserted the needle into a normal saline bag (single dose) attached to the blood lines. RN D drew out the normal saline into the syringe, administered Venofer (iron) into the venous drip chamber, and then used the normal saline syringe to flush the medication line. RN D did not use a pre-filled saline syringe to flush the medication line as per policy. On 09/26/2024 beginning at 9:10 AM, observed RN E administering intravenous (IV) medication to Pt #6 during dialysis treatment. RN E connected a needle to a syringe and inserted the needle into a normal saline bag (single dose) attached to the blood lines. RN E drew out the normal saline into the syringe, administered Venofer (iron) into the venous drip chamber, and then used the normal saline syringe to flush the medication line. RN E did not use a pre-filled saline syringe to flush the medication line as per policy. During interview with Director of Operations (DO) B and Clinical Manager (CM) C on 09/27/2024 beginning at 12:28 PM, while discussing observations, CM C stated that the RNs usually draw the saline flush off the normal saline IV bag at the patient station to flush the medication line (contrary to policy); CM C stated that pre-filled normal saline syringes are available at the facility and there is not currently a shortage.”

“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: 29972 Based on record review, observation and interview, staff failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination in 3 of 4 patients observed with a CVC (Patient #5, 8, 9) in a total sample of 4 patients observed with a CVC. Findings include: Review of policy and procedure #45664 titled, “Changing the Catheter Dressing Procedure” Published 02/05/2024 Version 8, revealed the following: -If using povidone pad (Betadine): “Using gentle friction, disinfect the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry for at least 2 minutes.” -If using 2% Chlorhexidine and 70% alcohol (Chloraprep): “Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds...” Review of policy and procedure #45640 titled, “Termination of Treatment Using A Central Venous Catheter...” version 7 published 02/07/2022 revealed, to prepare for the termination of dialysis “Ensure that a clean under pad is below the catheter limbs...” On 09/25/2024 beginning at 10:00 AM, observed Dialysis Technician (DT) F performing Pt #5’s CVC exit site care. DT F cleansed the skin surrounding the CVC exit site with Chloraprep for 20 seconds and not 30 seconds as per policy. Pt #5’s shirt was approximately an inch away from the exit site not allowing DT F to clean Pt #5’s CVC exit site in a concentric circle outward 2 inches as per policy. On 09/25/2024 beginning at 10:15 AM, observed DT F discontinuing Pt #9’s dialysis treatment using a CVC. DT F did not place a clean field under the CVC Ports as per policy. On 09/25/2024 beginning at 10:25 AM, observed Patient Care Technician (PCT) G performing Pt #8’s CVC exit site care. PCT G applied Betadine antiseptic to the skin surrounding the CVC exit site and allowed the antiseptic to dry for 1 minute and 45 seconds before applying the dressing; per policy, this antiseptic should be allowed to dry for 2 minutes. During interview with Director of Operations (DO) B and Clinical Manager (CM) C on 09/27/2024 beginning at 12:28 PM, while discussing observations, CM C stated that Betadine should be allowed to dry for 2 minutes as per policy. CM C confirmed that Chloraprep antiseptic should be applied for 30 seconds as per policy.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 29972 Based on observation, record review, and interview the facility staff failed to maintain a physical environment that is clean and free of potential infection control risks in 3 of 4 areas observed (Water room, Storage room, Technician Repair area), in a total sample of 4 areas observed. Findings Include: Review of policy #47685 titled, “General Cleanliness and Infection Control Guidelines,” Version 7 Published 07/01/2024 revealed the following: -All areas must be kept clean and organized, including but not limited to the treatment area, water/supply room and offices. -Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility. Review of the Housekeeping Contract (no date) revealed there was no documentation that the Housekeeping company was responsible for cleaning the Storage room. Observations on 09/25/2024 beginning at 12:15 PM, revealed the following concerns in the Water room, Storage room, Technician Repair area: -Observed cobwebs, accumulated dust, debris, packaging material/supplies, dead insects on floor behind the Chlorine tanks, Water Softener tank, Brine container, and Water Heater (Water room). -Observed accumulated dust/debris and packaging material/supplies on the floor under the supply carts (supply room). -Observed accumulated dust/debris and packaging material/supplies on the floor under the counters where Biomedical technician performs machine repairs/preventative maintenance (Technician Repair area). Per interview with Patient Care Technician (PCT) G on 09/25/2024 beginning at 12:20 PM, while observing the Water and Storage room, PCT G confirmed the findings and stated that there is no staff assignments/schedule to clean the water room. Per interview with Biomedical Area Lead J on 09/25/2024 beginning at 12:30 PM, while observing the Water and Storage room, Area Lead J confirmed the findings and stated that the floor in the Storage area should be cleaned daily by housekeeping staff (not in contract). Area Lead J stated that housekeeping do not clean the Water room and that staff is responsible for keeping the floors clean in the Water room. Area Lead J stated that he/she was not aware of a staff assignments/schedule developed to address the cleaning of the water/supply room as per policy.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 29972 Based on observation and interview staff failed to ensure that dialysis equipment is kept clean in 1 of 4 areas observed (Water room), in a total sample of 4 areas observed with dialysis equipment. Findings Include: On 09/25/2024 beginning at 12:15 PM, while touring the Water room with Patient Care Technician (PCT) G, observed the Acid Mixer equipment contain a large amount of accumulated white residue/dust and white pellets all over the top of the Acid Mixer in the Water room. Per interview with PCT G at the time of observation on 09/25/2024 at 12:15 PM; PCT G confirmed the findings and stated the staff should clean the Acid Mixer after each use. Per interview with Biomedical Area Lead J on 09/25/2024 beginning at 12:30 PM; Area Lead J confirmed the findings and stated that the Acid Mixer “...needs to get cleaned up.””

“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: 29972 Based on interview and record review the staff failed to ensure all members of the interdisciplinary team (IDT) meet as a team to discuss and share information to facilitate the development of the Plan of Care (POC) as per policy in 3 of 5 medical records reviewed (Pt #1, 4, 5), in a total sample of 5 records reviewed. Findings include: Review of policy and procedure #45283 titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” version 6 published 07/03/2023 revealed: - “The Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care must be developed and implemented by an interdisciplinary team consisting of at a minimum, the patient or patient’s designee, a registered nurse (RN), the patient’s attending physician...social worker (SW) and...registered dietician (RD).” - “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.” - “Each patient’s plan of care must be signed by all members of the IDT.” - “The Plan of Care should be signed at the time of the interdisciplinary team meeting for those attending in person...” Review of Pt #1’s medical record revealed Pt #1’s POC meeting was on 08/13/2024. Review of Pt #1’s POC “Team Approval Signatures” revealed there was no documented evidence of the RN, SW, and attending physician signing the POC, as evidence that the IDT met as a team to interact and share information from the comprehensive assessment to facilitate the development of the plan of care as per policy. Review of Pt #4’s medical record revealed Pt #4’s unstable POC meetings were on 07/23/2024 and 08/13/2024. Review of Pt #4’s POC “Team Approval Signatures” revealed there was no documented evidence of the RN, SW, and attending physician signing both POCs, as evidence that the IDT met as a team to interact and share information from the comprehensive assessment to facilitate the development of the plan of care as per policy. Review of Pt #5’s medical record revealed Pt #5’s POC meeting was on 07/18/2024. Review of Pt #5’s POC “Team Approval Signatures” revealed there was no documented evidence of the RN, SW, and attending physician signing the POC, as evidence that the IDT met as a team to interact and share information from the comprehensive assessment to facilitate the development of the plan of care as per policy. Per interview with RD K on 09/26/2024 beginning at 10:52 AM, RD K stated that the IDT does not always meet as a team to share information and formulate the POC. RD K stated that “we try” but are not “consistent” with meeting as a team. Per interview with SW L on 09/26/2024 beginning at 11:07 AM, SW L stated that the IDT does not typically meet as a team to discuss the POC. SW L stated that “who ever is here” meets with the patient for the POC meeting. SW L stated that the attending physician does not usually attend the POC meetings. Per interview with RN D on 09/26/2024 at 12:41 PM, RN D stated that the members of the IDT typically meet with the patient separately to discuss the POC, and the IDT does not usually meet together to share CIA information and discuss the POC.”

“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: 29972 Based on record review and interview, staff failed to follow prescribed blood flow rates and/or dialysate flow rates for 5 of 5 medical records reviewed (Patients #1, 2, 3, 4, 5), in a total sample of 5 medical records reviewed. Findings include: Review of policy and procedure #47334 titled, “Unable to Achieve Prescribed Blood Flow Rate” version 3 published 11/01/2021 revealed: - “Achieving prescribed BFR (Blood Flow Rate) is a critical parameter in achieving adequate treatment Kt/V (adequacy).” - “Notify physician/extender if unable to achieve prescribed blood flow rate.” - “Document in patient’s treatment record what action taken to address the inadequate blood flow and if unable to resolve. The nurse shall document any physician orders.” A review of Patient #1’s medical record revealed a physician order for BFR of 400 and DFR of 800. Review of Pt #1’s Dialysis Treatment Sheets revealed the following: -On 09/24/2024 the DFR was set at 700 from 7:33 AM until 8:32 AM. There was no documentation on the treatment sheet of the reason the DFR was not set at the ordered rate (800). -On 09/21/2024 the BFR was set at 450 during dialysis treatment. There was no documentation in the medical record of the reason the BFR was not set at the ordered rate (400). -On 09/19/2024 the BFR was between 475 and 535 during dialysis treatment. There was no documentation on the treatment sheet of the reason the BFR was not set at the ordered rate. A review of Patient #2’s medical record revealed a physician order for BFR of 400. Review of Pt #2’s Dialysis Treatment Sheets revealed the following: -On 09/21/2024 the BFR was set at 420 during dialysis treatment . There was no documentation in the medical record of the reason the BFR was not set at the ordered rate (400). -On 09/19/2024 the BFR was between 425 and 450 during dialysis treatment. There was no documentation on the treatment sheet of the reason the BFR was not set at the ordered rate. A review of Patient #3’s medical record revealed a physician order for BFR of 300 and DFR of 800. Review of Pt #3’s Dialysis Treatment Sheets revealed the following: -On 09/24/2024 the BFR was between 355 and 450 during dialysis treatment. There was no documentation on the treatment sheet of the reason the BFR was not set at the ordered rate (300). -On 09/21/2024 the BFR was between 400 and 450 during dialysis treatment and DFR was set at 500 from 9:38 AM until 10:34 AM (should be 800). There was no documentation in the medical record of the reason the BFR and DFR was not set at the ordered rate. -On 09/19/2024 the BFR was set at 350 during dialysis treatment. There was no documentation on the treatment sheet of the reason the BFR was not set at the ordered rate. A review of Patient #4’s medical record revealed a physician order for BFR of 350. Review of Pt #4’s Dialysis Treatment Sheets revealed the following: -On 09/24/2024 the BFR was set at 450 from 9:10 AM until 10:29 AM. There was no documentation on the treatment sheet of the reason the BFR was not set at the ordered rate (350). -On 09/21/2024 the BFR was set at 450 during dialysis treatment . There was no documentation in the medical record of the reason the BFR was not set at the ordered rate. -On 09/19/2024 the BFR was set at 400 during dialysis treatment. There was no documentation on the treatment sheet of the reason the BFR was not set at the ordered rate. A review of Patient #5’s medical record revealed a physician order for BFR of 450. Review of Pt #5’s Dialysis Treatment Sheets revealed the following: -On 09/19/2024 the BFR was set at 500 from 9:02 AM until 11:41 AM. There was no documentation on the treatment sheet of the reason the BFR was not set at the ordered rate (450). During interview with Director of Operations (DO) B and Clinical Manager (CM) C on 09/27/2024 beginning at 11:05 AM, while discussing medical record findings, DO B and CM C confirmed findings and stated that staff should following physicians orders for BFR and DFR.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 29972 Based on record review, observation, and interview staff failed to perform skin antisepsis as per policy when when using a Arteriovenous Fistula/Graft (AVF/G) in 2 of 2 observations of staff initiating treatment using an AVF/G (Patient (Pt) #10 and 11); and failed to assess the vascular access site after applying a clamp in 1 of 1 observations of staff using a clamp on the AVF/G as per policy (Pt #7), in a total sample of 4 observations of patients using a AVF/G. Findings Include: Review of policy and procedure #45178 titled, “Access Assessment and Cannulation” version 4 published 05-06-2024, revealed the following: - “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...” - “Perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection...” Review of policy and procedure #45175 titled, “Venipuncture Site Clamps” version 4 published 07/05/2022, revealed that after applying a clamp to “Check the access for the presence of a thrill. If a thrill is not present adjust clamp until you can feel a continuous thrill.” On 09/25/2024 beginning at 11:25 AM, observed Dialysis Technician (DT) I initiating Pt 10’s dialysis treatment using an AVF/G. DT I cleansed vascular access site #1 with an alcohol wipe for 11 seconds and retouched the clean skin prior to cannulation. DT I then cleansed site #2 for 10 seconds and retouched the clean skin prior to cannulation; DT I did not perform skin antisepsis for 30 seconds each site as per policy and retouched both vascular access sites prior to cannulation, potentially recontaminating the skin. On 09/26/2024 beginning at 9:38 AM, observed Patient Care Technician (PCT) H initiating Pt 11’s dialysis treatment using an AVF/G. PCT H cleansed the vascular access site #1 with an alcohol wipe for 15 seconds and then site #2 for 20 seconds prior to cannulation; PCT H did not perform skin antisepsis for 30 seconds each site as per policy. On 09/26/2024 at 9:50 AM, observed PCT H discontinuing dialysis treatment using Pt #7’s AVF/G. PCT H applied a clamp to the AVF/G and did not feel for a thrill (vibrating sensation) after applying the clamp as per policy. During interview with Director of Operations (DO) B and Clinic Manager (CM) C on 09/27/2024 beginning at 12:28 PM, while discussing observations, DO A and CM C stated that staff should scrub with alcohol wipe for 30 seconds prior to cannulation and staff should check for the thrill after applying a clamp to the AVF/G as per policy.”

“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: 29972 Based on observation, interview and record review, the facility failed to ensure nursing staff safely administer medications as per policy in 2 of 2 medication administration observations (Patient (Pt) #6 and 8), in a total sample of 2 medication administration observations. Findings Include: Review of policy and procedure titled, “Special Considerations: Venofer” version 3 published 07-01-2024 revealed, “Venofer (iron) may be administered undiluted as a slow intravenous injection over 2 to 5 minutes.” On 09/25/2024 beginning at 11:55 AM, observed Registered Nurse (RN) D administering intravenous (IV) Venofer to Pt #8 during dialysis treatment. RN D administered the Venofer over 1 minute, per policy it should be administered over 2 to 5 minutes. On 09/26/2024 beginning at 9:10 AM, observed RN E administering IV Venofer to Pt #6 during dialysis treatment. RN E administered the Venofer over 1 minute and 35 seconds, per policy it should be administered over 2 to 5 minutes. Per interview with with Director of Operations (DO) B and Clinic Manager (CM) C on 09/27/2024 beginning at 12:28 PM, while discussing observations DO B and CM C were not aware of the injection time of Venofer.”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 29972 Based on record review and interview staff failed to ensure all medical records have a date and time of each entry in 1 of 5 patient medical records reviewed (Patient (Pt) #2), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #46970 titled, “Medical Record Documentation Standards” version 4 published 02/05/2024 revealed: -Every entry in the medical record must include a complete date (Month, day and year) and have a time associated with it...” Review of Pt #2’s medical record revealed the following forms had no date and time documented: - “Keeping My Access Visible Agreement Form” Pt signed, but there was no date and time documented of when the education was provided. - “Patient Instructions for Care of the Dialysis Catheter” Pt signed, but there was no date and time documented of when the education was provided. - “Tuberculosis (TB) Risk Assessment Patient Questionnaire” Pt signed, but there was no date and time documented of when the TB questionnaire was completed. During interview with Director of Operations (DO) B and Clinical Manager (CM) C on 09/27/2024 beginning at 11:05 AM, while discussing medical record findings, CM C stated that there should be a date and time on the medical record forms observed.”