Carrollwood Artificial Kidney Center

“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: 34768 Based on observation, interview and record review the facility failed to follow infection control policies and procedures related to hand hygiene during care of a patient with dialysis access for 2 of 8 sampled patients (#1, #5). Findings included: Review of the facility’s policy, “Hand Hygiene,” published 11/06/2023 showed the purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination. Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content. 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 “ Entering and leaving the treatment area “ Before performing andy invasive procedure such as vascular access cannulation or administration of parenteral medications “ Immediately after removing gloves “ After contact with inanimate objects near the patient “ When moving from a contaminated bod site to clean body site of the same patient. “ After contact with other objects within the patient station or treatment space. On 08/04/2025 at 10:16 a.m. Patient #1 was sitting at station 12. Patient #1 had a Central Venous Catheter (CVC) in place. Staff A, RN was observed flushing the CVC (Central Venous Catheter) with medication with gloved hands. Staff A, RN with her gloved hands touched her name badge then accessed the dialysis machine. Staff A, RN removed and reapplied gloves without performing hand hygeine. Staff A, RNs name badge was observed hanging from her neck into the sterile field of Patient #1. Staff A, RN was observed cleaning the CVC ports and flushing the ports. Staff A, RN removed her gloves and hand sanitized. Staff A, RN went to medication cart, across the dialysis floor to obtain the heparin for the patient. Staff A, RN touched the heparin bottle. Staff A, RN went around the medication cart to the computer and looked up something. Staff RN returned to the medication cart and drew up the heparin for Patient #1. Staff A, RN applied gloves at the medication cart and while ambulating back across the dialysis floor to station 12, she touched her stethoscope with her gloved hands. Staff A, RN used alcohol wipes to clean the ports and flushed the ports. Staff RN replaced the caps. Staff A, RN replaced the gauze on the CVC ports. Staff A, RN removed her gloves and hand sanitized. On 08/04/2025 at 10:48 a.m. Patient #5 was sitting at station 6. Patient #5 had a Central Venous Catheter (CVC) in place. Staff A, Registered Nurse (RN) was observed putting on one glove without hand sanitizing at the medication cart which was located at one end of the dialysis floor. Staff A, RN was observed placing second hand onto the medication cart and then putting on second glove without hand sanitizing. Staff A, RN was observed ambulating across the dialysis floor to station #6 with a syringe in her gloved hands. Staff A, RN was observed touching / adjusting her face shield with her gloved hands. Staff A, RN administered the medication into Patient #5’s CVC. Staff A, RN was observed removing her gloves, touching her face shield and then hand-sanitizing. During an interview on 08/05/2025 at 1:27 p.m. Administrator / Director of Nursing (Adm/DON) stated the Staff A, RN had infection control breaks. Adm/DON stated he expected the staff to follow the infection control policy. The staff was to hand sanitize before and after patient care and glove changes. Adm/DON stated the staff was not to walk around the floor with gloves on.”

“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: 42154 Based on observation and interviews it was determined that the facility failed to maintain a clean and dirty area where clean unused supplies are located in one of one observation. Findings included: On 08/04/2025 at 10:21 AM a staff members blue work bag was next to the clean dialyzer filter and IV (Intravenous)fluid bags. A day planner sitting on top of the IV fluid bags. During an interview on 08/04/2025 at approximately 10:30 AM, Staff A, RN said that the blue bag is hers and “I have to move it.” During a discussion on 08/04/2025 at approximately 1:00 PM with the Director of Operations she was shown the photo evidence, she disclosed that the staff has lockers in the back, and their belongings should not be on the dialysis unit. Photographic evidence obtained.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 42154 Based on observation and interviews, the facility failed to ensure supply carts are located a sufficient distance from patient stations to avoid cross contamination in two of four supply carts. Findings included: On 08/04/2025 at 9:04 AM a supply cart was located between station # #14 and station # 13, with a patient family member within close proximity (approximately 10 inches) to supply cart. On 08/04/2025 at 9:07 AM a supply cart with bags of Bicarbonate (helps maintain the acid-base balance) between station #10 and station #17 with patients actively receiving treatment at the stations. On 08/04/2025 at 9:49 AM a supply cart with Bicarbonate bags near station #10. The Patient’s belongings noted to be next to (approximately 7 inches) from the supply cart. During an interview on 08/04/2025 at 1:00 PM photo evidence was shared with the Director of Operations, she disclosed that the staff needs the supply cart and the facility is small. Photo evidence obtained.”

“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: 42154 Based on facility policies, observations and interviews, the facility failed to properly disinfect stations between patient care in three of five observations of oxygen concentrators. Findings included: Review of the policy and procedure titled, “Cleaning and Disinfecting the Dialysis Station”, dated 09/05/2023 revealed that the Center for Medicare and Medicaid services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients ...dialysis station area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment ... During a flash tour on 08/04/2025 at 9:00 AM in the dialysis center upon entrance into the unit, a patient receiving dialysis at station #1 was noted to have an unused oxygen concentrator at chair side. During a tour on 08/04/2025 at approximately 9:30 AM on the dialysis unit, a patient receiving treatment at station #21 was noted to have an unused oxygen concentrator at chair side. On 08/04/2025 at approximately 9:33 AM during a tour of the dialysis unit, a patient receiving treatment at station #19 was noted to have an unused oxygen concentrator at chair side. On 08/04/2025 at 9:46 AM, a patient camr in to receive dialysis treatment at station #1. There was an oxygen concentrator still at chair side. During an interview on 08/04/2025 at 10:00 AM with Staff A, Registered Nurse (RN) , she said that the staff is to clean the oxygen concentrator and move off the dialysis unit into the back room after every patient. On 08/04/2025 at approximately 10:10 AM Staff D, Certified Clinical Hemodialysis Technician (CCHT) and Staff C,CCHT cleaned the unused oxygen concentrators and moved them to the back room after Staff A, RN spoke with them. Photo evidence obtained.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 42154 Based on facility policy, personnel files, and interviews it was determined that the facility failed to ensure annual training for infection control was completed in one (staff A) of 6 reviewed. Findings included: Policy titled, “Employee files” effective 09/21/2021 ...document ...infection control information upon hire and annually Review of personnel files revealed that Staff A, RN annual education for infection control and OSHA is 31 days overdue. During a discussion on 08/05/2025 at approximately 10:00 AM with the Administrator, he stated that Staff A is overdue for some annual education. He did disclose that it should have been done by July 05, 2025.”

“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: 34768 Based on interview and record review the facility failed to achieve and sustain the prescribed dose of dialysis to meet the prescribed Dialysate Flow Rate (DFR) for four of eight sampled patients (#1, #4,#5, #8) and Blood Flow Rate (BFR) for four of eight sampled residents (#1, #4, #5, #8). Findings included: 1. Review of the medical record showed Patient #1 was admitted to the facility on 05/09/2025 to receive dialysis three times a week with a Central Vascular Catheter (CVC). Review of the physician’s orders revealed a DFR of 1.5 autoflow or 600 milliliters/minute and a BFR of 350 ml/min. On 07/30/2025 the DFR was documented as 700 ml/min for 4 out of 8 assessments. The BFR was documented as 400 ml/min for 8 out of 8 assessments. On 08/01/2025 the BFR was documented as 400 ml/min 8 out of 8 assessments. There was no justification documentation noted as to why BFR and DFR were not followed. 2. Review of the medical record showed Patient #4 was admitted to the facility on 07/13/2025 to receive dialysis three times a week with a fistula. Review of the physician’s orders revealed a DFR of 800 ml/min and BFR of 450 ml/min. On 07/22/2025 the BFR was documented as 350 ml/min for 8 out of 9 assessments and the DFR was documented as 500 ml/min for 9 out of 9 assessments. On 07/24/2025 the BFR was documented as 300 ml/min for 8 out of 9 assessments. On 08/02/2025 the BFR was documented as 400 ml/min for 7 out of 8 assessments. There was no justification documentation noted as to why BFR and DFR were not followed. 3. Review of the medical record showed Patient #5 was admitted to the facility on 10/25/2024 to receive dialysis three times a week with a CVC. Review of the physician’s orders revealed a BFR of 350 ml/min and DFR of 1.5 autofill or 600 ml/min. On 08/01/2025 the BFR was documented as 400 ml/min for 10 out of 10 assessments. The DFR was documented as 800 ml/min for 11 out of 11 assessments. There was no justification documentation noted as to why BFR and DFR were not followed. 4. Review of the medical record showed Patient #8 was admitted to the facility on 03/07/2025 to receive dialysis three times a week with a CVC. Review of the physician’s orders revealed a DFR of 800 ml/min and BFR of 400 ml/min. On 07/21/2025 the BFR was documented 350 ml/min for 11 out of 11 assessments. On 08/01/2025 the BFR was documented as 350 ml/min for 8 out of 9 assessments. There was no justification documentation noted as to why BFR and DFR were not followed. During an interview on 08/05/2025 at 9:06 a.m. the Facility Administrator / Director of Nursing (FA/DON) verified the BFRs and DFRs were not followed and there was no justification documented in the medical record. The FA/DON stated it looks like the DFR was set wrong. The FA/DON stated he expected the orders to match or a notation as to why they did not match. Review of the facility’s policy, “Patient Assessment and Monitoring,” dated 05/01/2023 showed the purpose of this policy is to provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during and after treatment. Machine Parameters and extracorporeal Circuit: Check machine settings and measurements: “ Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. “ Check dialysate flow rate setting is correct, and the prescribed flow is beign deliver”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 42154 Based on facility policy, facility documents and interviews it was determined that the facility failed to perform an extensive review of patient deaths in 4 months (March, April, May, June) of 4 month reviewed. Findings included: Reviewed the Policy and Procedure titled, “Quality Assessment and Performance Improvement Program”, # 25799 dated 11/04/2024 ...QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes ... Review of the QAPI worksheet revealed that the facility had mortalities in March 2025 was one death (cardiac arrest), April 2025 with 3 deaths (one with cardiac arrest), May 2025 one death (cardiac arrest) and June 2025 one death (cardiac arrest). During a discussion on 08/05/2025 at 12:35 PM with the Director of Operations disclosed that there is a trend and there are a lot of cardiac arrest, we can do better with documentation and discuss with our medical director in Quality assessment, she also said that she should be able to pull up the notes and it should have everything documented there.”