Usrc Tampa Central

“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: 20536 Based on observations, interviews and record review, the facility failed to ensure patient treatment spaces and patient equipment were clean, sanitary and maintained during two of two days observed, (12/29/2025, and 12/30/2025). Findings included: On 12/29/2025 during facility space tours at 7:58 a.m., 11:45 a.m., 2:00 p.m., and again on 12/30/2025 at 7:15 a.m. and 11:00 a.m. the following was observed: a. The clean sink area in the supplies cabinet area was observed. Upon pushing the foot pedal to turn on the water, the flow was very low. There was a sewage odor emitting from the drain in the sink. There were five small black flying insects coming from and flying around the sink basin, especially around the drain area. b. The medication refrigerator, positioned across from the nurse station was observed with heavily rusted metal vent/grating. The surface was left non cleanable from the rust. There were personal belongings and a stethoscope laying bare on top of the refrigerator. Photographic evidence was taken. c. The wall/counter area back behind patient station #17 was observed with a board in disrepair and leaving a gap/hole. This area was not cleanable. There was a patient seated in the chair receiving treatment at this area. There were black spots and debris on the gray facing of the lower counter wall area. d. A wall mounted electronic hand hygiene dispenser located near station 15, was noted with a red flashing light. Upon reaching to the sensor, it did not provide any product. It was found the dispenser was not working. e. The “Dirty” sink area and counter near station #15 was observed with plastic siding in disrepair, leaving non cleanable surface, and with the counter soiled with liquid and other debris. f. Station #11, which was just disinfected, was observed with a blood pressure cuff partially laying on the bare ground. Second observation of this BP cuff on the floor at 9:40 a.m. The cuff was partially on the floor for over 45 minutes. g. Station #17, which was just disinfected, was observed with a blood pressure cuff partially laying on the bare ground. Second observation of this BP cuff on the floor at 9:45 a.m. The cuff was partially on the floor for over 30 minutes. h. Dialysis machine #14 was observed with a patient receiving treatment up until 9:15 a.m. Staff C, Personal Care Technician (PCT) disinfected the machine but missed the bottom half of the machine. The front lower facing of the machine had what appeared to be tan in color spill marks from liquid. The same observation was made later at 10:10 a.m. i. One ceiling tile above station 10/11 was observed water soaked and brown in color with water staining. The wallpaper underneath the soiled tile was observed in disrepair and separated from the wall, due to water damage. j. The nurse station wall column was observed with a wall mounted hand sanitizer dispenser. The dispenser had a red light flashing. Upon reaching to the sensor, it did not provide any product. It was found the dispenser was not working. k. A wall column at the nurse station near the supplies cabinets was observed with a wall mounted hand sanitizer dispenser. The dispenser had a red light flashing. Upon reaching to the sensor, it did not provide any product. It was found the dispenser was not working. l. A wall mounted hand sanitizer dispenser near the medication refrigerator revealed upon reaching to the sensor, it did not provide any product. It was found the dispenser was not working. m. Three of the ceiling vents and surrounding ceiling tiles were observed with built up caked on dust/debris. The vents were observed directly above patient treatment stations. n. The back wall counter space behind treatment station 17/16 revealed a wooden wall plate detached and leaving a large hole. Further, the facing of the wall plate and walls were observed with black biogrowth. Photographic evidence was taken. On 12/30/2025 at 11:00 a.m. a tour was conducted of the patient treatment floor with the Regional Director of Operations/Clinical Specialist (RDO). She was able to verify the above listed concerns. She revealed the facility is going through a renovation process and provided plans dated 6/24/2025. The plans identified many areas to be renovated. Though the facility had plans since 6/24/2025, it was found the above listed concerns mainly revealed cleanliness maintenance issues which were not part of renovation. The RDO Clinical Specialist revealed the facility has a private cleaning company that comes out every night to clean things such as floors, walls, ceiling, and high touch surfaces, as well as removal of trash. She confirmed the cleaning company should have cleaned the above mentioned areas of concern. On 12/30/2025 at 11:30 a.m. the RDO Clinical Specialist provided the “Disinfection and Cleaning of Dialysis Machine Equipment” policy and procedure with a revision date of 10/2025 for review. The policy revealed: Purpose - To provide guidance on proper disinfection of the dialysis station, machine, equipment, and surrounding surfaces with the appropriate method prevents the transmission of disease/infection to the dialysis population. Policy - 1. A 1:100 dilution bleach solution will be made daily (or per stricter state regulations) and discarded at the end of the day. 3 . The bleach solution will have at least a five(5) minute contact time as per manufacturer’s recommendation for external disinfection of non-disposable items, dialysis machines, dialysis chairs and related surfaces. 4 . Complete surface disinfection at the end of each dialysis treatment after the patient has vacated the station. Disinfection procedure: 2 . Follow manufacturers instructions for disinfection of the dialysis machine, chair, and related equipment. Follow instructions for appropriate disinfectant and appropriate contact time. 6 . Obtain at least one (1) clean moistened 1:100 bleach cloth for the machine, one (1) for the chair and one (1) for ancillary equipment (oxygen concentrator/acid jug/TV/TV remote). 7 . Clean all external surfaces of the dialysis machine to include top, sides, front and back, BP cuffs and basket; dialysate connectors and lines; bicarb/acid lines connecting machine to monitors and keyboard/mouse. 8 . Disinfect all surfaces of the prime waste container, inside and out, with moistened 1:100 bleach cloth. 9 . Clean counter tops behind patient station. 42154 On 12/29/2025 at approximately 8:30 AM a tour of the dialysis unit revealed that at station #11 cleaned with the blood pressure cuff hanging off the table and touching the floor. Staff D PCT brought over Patient #13 and set her up in station #11 and placed the blood pressure cuff on the patient’s right arm without recleaning the cuff. On 12/29/2025 at approximately 8:30 AM the tour of the dialysis unit revealed that a dirty (used) oxygen concentrator was noted to be next to the nursing station under the staff gloves, stethoscope, and clean supplies. On 12/29/2025 at approximately 8:54 AM Staff B, Licensed Practical Nurse (LPN) cleaned station 6 after Patient #11 had treatment but failed to clean the back counter. Observed Staff B, LPN bring Patient #12 from the lobby and had her sit in station #6 for her treatment to begin at approximately 10:10 AM. On 12/29/2025 at approximately 9:09 AM observed Staff B, LPN cleaned station 7 after Patient #9 treatment, but failed to clean the back counter. Observed Patient #9 removing his jacket hanging from the PPE (Personal protective equipment) hooks for staff when he was leaving the facility after treatment. On 12/29/2025 at approximately 10:16 AM observed Staff D, PCT remove the Hoyer lift that had not been cleaned and utilize the lift to move a patient from their wheelchair to a dialysis recliner, the staff failed to clean the Hoyer lift after the transfer. On 12/30/2025 at approximately 9:15 AM an oxygen concentrator was observed being utilized by a patient sitting in station 10. Staff B, LPN moved the used oxygen concentrator next to the nursing station after patient dialysis completed. Oxygen concentrator was not cleaned and still next to the nursing station at 12:30 PM. During a discussion on 12/30/2205 at approximately 11:10 AM with the Administrator/ Clinical Nurse and the Regional Clinical Services they said that they identified the staff not cleaning the station properly during the survey and they will talk with the staff regarding the patients jacket hanging on the staff PPE area as well as the equipment needing to be cleaned immediately after use.”

“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: 20536 Based on record review and interviews, the facility failed to ensure prescribed Blood Flow Rate (BFR), and Dialysate Flow Rate (DRF) were followed for three of eight sampled patients, (#3, #4 and #7). Findings included: On 12/30/2025 during record review for Patient #7, it was found he was admitted for Dialysis services on 1/8/2021. Patient #3 had an admitting diagnosis of End Stage Renal Disease (ESRD) and with current treatment orders starting on 12/1/2025. Review of order/assessment “In Center: Conventional” document #276113258 with a start date of 12/20/2025, revealed Dialysate information to include: Dialyser - OPTIFLUX 180 NR with a required Blood Flow Rate (BFR) of 400 and a Dialysate Flow Rate (DFR) of 800. Review of the following treatment visits for Patient #7 revealed: 1. Hemodialysis Flow sheet dated 12/16/2025 revealed ordered BFR rate at 400 and DFR rate at 800. The sheet further revealed at 12:01 the DFR was 700; at 12:32 DFR was 600; 12:53 the DFR was 600; 13:01 BFR was 0 and DFR was 600; 13:06 DFR was 500; 13:16 DFR was 500; 13:39 DFR was 500, 14:02 BFR was 351 and DFR was 500; 14:19 BFR was 349 and DFR was 500; 14:32 BFR was 349 and DFR was 500; and 14:55 BFR was not documented, and DFR was not documented. 2. Hemodialysis Flow sheet dated 12/18/2025 revealed ordered BFR rate at 400 and DFR rate at 800. The sheet further revealed at 12:18 the BFR and DFR were not documented leaving unknown values at the end of the treatment. 3. Hemodialysis Flow sheet dated 12/20/2025 revealed ordered BFR rate 400 and DFR rate at 800. The sheet further revealed at 08:50 BFR was 200; 11:55 BFR was not documented and it was not known of the value at the end of treatment. 4. Hemodialysis Flow sheet dated 12/24/2025 revealed ordered BFR rate 400 and DFR rate 800. The sheet further revealed at 15:33 BFR was 450; 16:03 BFR was 450; 16:33 BFR was 450; 17:03 BFR was 450; 17:32 BFR was 450; 18:02 BFR was 450; and 18:46 BFR and DFR were not documented. It was not known of the values at the end of treatment. 5. Hemodialysis Flow sheet dated 12/27/2025 revealed ordered BFR rate 400 and DFR rate 800. The sheet further revealed at 10:30 BFR and DFR not documented; 10:51 BFR and DFR not documented. It was not known of the values at the end of treatment. Further review of Patient #7’s record to include the nursing notes sections in all the above listed Flow sheets, revealed no indication of any type of change order, or notification of reasons for deficient BFR and DFR flow rates. There was no indication staff were addressing the flow rates that were not followed as ordered. On 12/30/2025 at 11:00 a.m. an interview with the Facility Administrator (FA) and the Regional Director of Operations (RDO) both confirmed BFR and DFR flow rates as listed above did not meet the physician’s orders and there was no documentation to support staff identifying, addressing and reporting the wrong flow rates for Patient #7. On 12/30/2025 during record review for Patient #3, it was found she was originally admitted for Dialysis services on 1/2/2025 and with a more current start date on 7/16/2025.. Patient #3 had an admitting diagnosis of End Stage Renal Disease (ESRD) and with current treatment orders starting on 7/16/2025. Review of order/assessment “In Center: Conventional” document #263787600 with a start date of 7/16/2025, revealed Dialysate information to include: Dialyser - OPTIFLUX 160 NRE with a required Blood Flow Rate (BFR) of 400 and a Dialysate Flow Rate (DFR) of 600. Review of the following treatment visits for Patient #3, revealed: 6. Hemodialysis Flow sheet dated 11/19/2025 revealed ordered BFR rate 400 and DFR rate 600. The sheet further revealed at 08:40 BFR was 200; 09:33 BFR was 350; 10:02 BFR was 350; 10:32 BFR was 350; 11:18 BFR was 350; 11:44 BFR was 350; 12:09 BFR was 350 and DFR was 300. 7. Hemodialysis Flow sheet dated 11/21/2025 revealed ordered BFR rate 400 and DFR rate 600. The sheet further revealed at 08:49, 08:57, 08:58, 09:30, 10:00, 10:30, 11:00, 11:30, 12:08, and 12:35 revealed BFR and DFR were not documented. There was no evidence of what the known values were. Also, at 12:31 the BFR was documented as 200. 8. Hemodialysis Flow sheet dated 11/26/2025 revealed ordered BFR rate 400 and DFR rate 600. The sheet further revealed at 09:26 the BFR was 200; 12:00 and 12:41 BFR and DFR not documented at all, and 12:56 BFR was 200. 9. Hemodialysis Flow sheet dated 11/24/2025 revealed ordered BFR rate 400 and DFR rate 600. The sheet further revealed at 08:05 BFR documented as 60 and DFR as not documented at all; 11:45 BFR was 300. 10. Hemodialysis Flow sheet dated 11/28/2025 revealed ordered BFR rate 400 and DFR rate 600. The sheet further revealed at 09:37 the BFR rate was 200; 10:00; 10:30; 13:08 the BFR and DFR were not documented at all. It could not be determined what the values were at the end of the treatment. Further review of Patient #3’s record to include the nursing notes sections in all the above listed Flow sheets, revealed no indication of any type of change order, or notification of reasons for deficient BFR and DFR flow rates. There was no indication staff were addressing the flow rates that were not followed as ordered. On 12/30/2025 at 11:00 a.m. an interview with the Facility Administrator (FA) and the Regional Director of Operations (RDO) both confirmed BFR and DFR flow rates as listed above did not meet the physician’s orders and there was no documentation to support staff identifying, addressing and reporting the wrong flow rates for Patient #3. On 12/30/2025 at 12:00 p.m. the FA provided the “Electronic Medical Records Application” policy and procedure with a last revision date 2/2024 for review. The policy revealed: Purpose - To outline medical records content in the Electronic Medical Record (EMR). Policy - The listed medical record components will be maintained in PEARLCare. All electronic records are maintained in accordance with established standards, backed up daily to prevent loss of data and stored in centralized computer serves. #8 ORDERS: c. Additional orders; i . Physician’s orders optional templates in notes module. #14 TREATMENT FLOW SHEETS: Completed for each patient treatment. If the server or internet is down: a. A manual paper flow sheet will be used for documentation. 42154 Review of the medical record showed Patient #4 showed his first dialysis treatment was 12/07/2024 with primary cause of ESRD to be hypertensive chronic kidney disease was ordered on 12/12/2025 that the BFR at 400 ml/minute. Review of the treatment sheets for 6 treatments revealed that on 12/22/2025 the treatment for the BFR was at 300 ml/minute and on 12/26/2025 the treatment for the BFR was at 350 ml/minute. There was no justification documentation noted as to why BFR orders were not followed. Further review of the treatment sheet showed that on 12/20/2025 there were incomplete documentation on the values which prevented the values at the end of the treatment. During a discussion on 12/30/2025 at 11:08 AM with the Administrator/ Clinical Nurse regarding BFR and DFR and she stated that the BFR fluctuates between 5 to 7 and the DFR does not change. She disclosed that it will not fluctuate by 50 or 100. The Administrator / Clinical Nurse disclosed that the document should automatically cross over and if it did not then it was probably a one off. The surveyor informed her that it has occurred more than once on different days and different patients she said that she will look into it.”

“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 documents and interviews, the facility failed to do a comprehensive review of mortality in 2 (2024 and 2025) of 3 years reviewed. Findings included: Review of the facility documents titled “Mortality Root Cause Tool” for 2025 showed that there were 4 deaths but no evidence that the mortalities were reviewed for cause of death and the relationship to the center. No documents provided for 2024 that there were any mortalities. During an interview on 12/30/2025 at 11:15 AM with the Facility Administrator (FA) that the Administrator assistant (AA) usually fill out the form. The FA further revealed she did not have any type of documentation to support a comprehensive root cause assessment with regards to specific causes of death. The FA verified that there is not a 2024 Mortality root cause tool. During an interview on 12/30/2025 at approximately 11:15 AM with the Regional Clinical Services mentioned that they would only do a comprehensive root cause assessment with specific cause of death if they broke the threshold that the corporation sets out and that they have not broken that threshold, the rate mortality 2.2% and target is at 8.0%, anything above that then the facility will look further into what the actual problem was. She disclosed that the facility will do better by filling out the mortality log.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 42154 Based on policy, record review and interview the facility failed to do complete documentation on dialysis treatment which prevented the values at the end of treatment to show sufficient flow clearance, quality and efficiency, good solute clearance and crucial warning signs of potential access problems, in 4 (#3, #4, #6 and #7) out of 7 in center dialysis medical record reviewed. Findings included: Policy and Procedure titled “Electronic Medical Records Application” policy and procedure with a last revision date 2/2024 for review ...Purpose - To outline medical records content in the Electronic Medical Record (EMR) ...Policy - The listed medical record components will be maintained in PEARLCare. All electronic records are maintained in accordance with established standards, backed up daily to prevent loss of data and stored in centralized computer serves ...TREATMENT FLOW SHEETS: Completed for each patient treatment. If the server or internet is down: a. A manual paper flow sheet will be used for documentation. Review of the medical record showed Patient #4 first dialysis treatment was 12/07/2024 with primary cause of End Stage Renal Disease (ESRD) to be hypertensive chronic kidney disease. Review of the treatment sheets on 12/20/2025 showed there were incomplete documentation during the treatment which prevented the values at the end of their treatment which would have shown the average blood flow (maintaining sufficient flow for clearance while minimizing stress on the access site), total blood processed (amount of patient blood that ran through the machines circuit which is the key metric recorded for quality and efficiency), max dialysate flow (ensure good solute clearance before treatment finishes), and venous pressure (crucial warning signs of potential access problems). Review of the medical record forPatient #3 showed that on 11/21/2025,11/26/2025, and 11/28/2025 incomplete documentation during the treatment which prevented the values at the end of their session. Review of the medical record showed Patient #6 first dialysis treatment was 06/26/2018 with primary cause of ESRD as hypertensive chronic kidney disease. Reviewed the treatment sheets for 6 treatment days and on 12/15/2025, 12/17/2025, 12/24/2025 and 12/26/2025 all showed incomplete documentation during the treatment which prevented the values at the end of their session. Review of the medical record for Patient #7 showed that on 12/16/2025, 12/18/2025, 12/20/2025, 12/24/2025, and 12/27/2025 incomplete documentation during the treatment which prevented the values at the end of their session. During a discussion on 12/30/2025 at 11:08 AM with the Administrator/ Clinical Nurse disclosed that the document should automatically cross over and if it did not then it was probably a one off. The surveyor informed her that it has occurred more than once on different days, and different patients said that she will look into it.”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 34768 Based on observations, interviews and record reviews the facility failed to perform a quality assessment and performance improvement program which identified the problem and and found resolution regarding infection control protocols related to hand sanitizing between donning and doffing of gloves, and use of barriers for 3 of 8 sampled patients (#1, #2, #3). Findings included: Review of the facility’s policy, “Introduction to Quality Assessment and Performance Improvement (QAPI)”, revised 01/2020 showed a quality assessment and performance improvement program (QAPI) is a well-defined organized program which monitors standards of patient care. The process includes systematically examining patient care, identifying deficiencies, establishing priorities, searching for a probable cause, generating and choosing a solution, implementing the solution and then re-examining the case. The purpose of the program is to establish effective problem-focused review and evaluation of the quality, safety, and appropriateness of patient care. The components of the program ar based on logical principles of evaluation and ca be used to focus specifically on problems whose resolutions will have a significant and positive impact on patient care and clinical performance. The commitment of ESRD facility leadership is essential to the success of the QAPI program. The program should be comprehensive, yet flexible enough to permit innovation and variation in assessment approaches. The QAPI program must be reviewed and approved by the facility Governing Body. Program Responsibility: Facility: the facility Governing Body is responsible for establishing, maintaining, supporting, and documenting an on-going QAPI program. The Medical Director is ultimately responsible for the overall quality of the facility’s operation. Program Characteristics The “Key Characteristics of an effective QAPI program” as described by CMS are the following: A central committee for quality assessment and performance improvement There are structural procedures for problem analysis There is a method to prioritize opportunities identified for improvement The QAPI Committee develops appropriate recommendations The Medical Director of the facility is responsible for the implementation of changes recommended by the QAPI Committee The QAPI Committee conducts regular, periodic re-audits to assess action results The Governing Body of the facility periodically evaluates the QAPI Program An observation was performed on 06/06/2024 at 10:50 AM of Staff A, Patient Care Technician (PCT) performing Central Venous Catheter (CVC) initiation and care of exit site for Patient #2 at station 6. Staff A placed a clean drape on the patient’s chest and then placed the dirty gauzed covered CVC lumens / ports on the clean drape. The dirty gauze was removed, and the lumens / ports were placed on the drape. The Exit Site Dressing was not changed at this time. Staff A proceeded with the care and cannulation of the CVC without hand sanitizing and / or changing gloves. An observation was performed on 06/06/2024 at 11:09 AM of Staff A, PCT performing access of a fistula for Patient #3 at station 10. Staff A used a stethoscope to check the bruit of the fistula and he replaced the stethoscope on a hook without cleaning it. Staff A was observed removing his gloves, going to the supply cabinet across the floor area, without hand sanitizing, walking back, replacing his gloves and continuing with the cannulation of the patient. Throughout the access Staff A did not hand sanitize between glove changes. An observation was performed on 06/06/2024 at 11:20 AM of Staff C, PCT performing CVC initiation and care of the exit site for Patient #1 at station 3. Staff C placed the clean drape on the patient’s chest then placed the dirty gauzed covered CVC lumens / ports on the clean drape. Staff C removed her gloves, hand sanitized, replaced her gloves and performed exit site care. Staff C removed her gloves, hand sanitized, touched the back of the chair she was sitting in and then applied gloves. She proceeded with the initiation of dialysis through the CVC. An observation was performed on 06/06/2024 at 11:20 AM of Staff A, PCT walking around the floor area with used gloves in his hand. He returned to his area and donned gloves without hand sanitizing. During an interview on 06/06/2024 at 11:30 AM Staff D, PCT stated that they were educated on hand hygiene between glove changes, when in contact with the patient, before leaving area. She stated they did not discuss the gauze around the catheter ports. During an interview on 06/06/2024 at 11:46 AM the Facility Administrator / Director of Nursing (FA / DON) stated that she performed the education regarding infection control with the staff. She stated they reviewed washing hands and donning full PPE. She stated she printed out the policies and went over them, they included the following: “Hand Hygiene”, “Infection Control and Precautions for All Patients”, “Dialysis Catheter Dressing Change”, and “Iron Protocol and Administration”. She reviewed the policy, “Accessing and De-Accessing the Dialysis Catheter,” which included donning full PPE (Personal Protective Equipment) including mask; assist patient to don mask. Remove the gauze and tape from catheter lumens if present. Remove gloves, perform hand hygiene and don clean gloves. Place the under pad beneath the catheter lumens. Replace under pad if soiled. She stated after reviewing the “Dialysis Catheter Dressing Change” policy that it did not address removing the gauze on the catheter lumens and the clean drape. She stated this may have been part of the confusion. She stated the drape would have been contaminated after laying the dirty gauze covered ports on the drape. She stated all the staff was educated and she provided a sign-in sheet for the education. She stated she audited daily times 5 days, then weekly times 2 weeks and now infection control was being audited monthly. The DON stated she used the following CDC (Centers for Disease Control and Prevention) forms for the audits: hand hygiene, catheter care exit observation, catheter and connection and disconnection, and hemodialysis routine disinfection observation. She stated she had observations of Staff A, PCT not performing hand sanitation during her audits. The Quality Assurance (QA) meeting met formally on 05/30/2024 (after the Plan of Correction (POC) completion date). They discussed their normal QA agenda as well as the survey results. She stated the Medical Director was called after the survey team exited and was notified of the possible deficiencies. She stated she created the POC with the Clinical Specialist after we exited the survey. Review of the facility’s policy, “Hand Hygiene,” revised on 08/2020 showed the purpose was to give guidance on proper hand hygiene and avoid the transmission of harmful germs and prevent healthcare-associated infections. Hand Hygiene will be performed: 1. Before and after touching a patient. 2. Prior to entering and on exiting station to provide care to patient. 3. Prior to contact with vascular access site. 4. Prior to adjusting or removing cannulation needles. 6. Before clean/aseptic procedure (e.g. vascular access cannulation/decannulation, catheter care or administration of parenteral medications). 7. After body fluid exposure risk. 8. After touching patient surroundings (e.g. dialysis machine, any items in the dialysis are or chairside computers). 9. After gloves are removed. 10. Before and after touching PPE. 11. After contact with inanimate objects, including medical equipment or environmental surfaces at the patient station. 12. Before entering and on exiting the patient treatment areas. 13. When moving from a contaminated body site to a clean body site of the same patient. 14. After handling biohazardous waste. Review of the facility’s policy, “Accessing and De-Accessing the Dialysis Catheter,” revised 02/2023 showed to avoid potential catheter contamination or undue injury to the patient and provide guidelines to properly access and de-access the dialysis catheter using aseptic technique. POLICY: Any connection/disconnection of the dialysis bloodlines to/from the catheter ports will be performed by staff trained and deemed competent. PROCEDURE: 1. Don full PPE including mask; assist patient to don mask. 2. If unable to perform catheter dressing change before initiation of treatment, don clean gloves to lift the dressing to assess the site and condition of the catheter and then replace until dressing is changed. 3. Remove the gauze and tape from catheter lumens if present. 4. Remove gloves, perform hand hygiene and don clean gloves. 5. Place the under pad beneath the catheter lumens. 6. Hub disinfection. a. using aseptic technique, grasp the catheter and remove cap from the port. B. Disinfect the hub with an alcohol prep pad with the other hand. Scrub the end of the hub and sides thoroughly with friction, making sure to remove any residue. C. Using the same alcohol prep pad, apply alcohol with pressure to the catheter, moving from the hub at least several centimeters towards the body. 12. Initiate dialysis per procedure, incrementally increasing BFR to the prescribed rate monitoring arterial and venous pressures. Remove patient’s mask. Replace under pad if soiled.”

“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 protocols related to hand sanitizing between donning and doffing of gloves, cleaning stethoscope between patient uses and using a barrier for 3 of 4 sampled patients. Findings included: An observation was performed on 04/25/2024 at 10:25 a.m. of Staff A, Registered Nurse (RN) performing Central Venous Catheter (CVC) initiation and care of exit site for Patient #8 at station 4. Staff A, RN removed her gloves and applied her gloves throughout the procedure without hand sanitizing between glove changes. Staff A placed a clean drape on the patient’s chest and then placed the dirty gauzed covered CVC ports on the clean drape. Staff A removed the old dressing and discarded, performed a glove-to-glove change. During the cleaning of the site, Staff A performed a glove-to-glove change without hand sanitizing. Staff A removed the dirty gauze from the CVC ports and laid the ports on the contaminated drape. Staff A removed her gloves, walked outside the patient area to a cabinet to retrieve supplies, she then returned and applied gloves. Staff A then performed the initiation of the dialysis with multiple glove-to-glove changes without hand sanitizing between. An observation was performed on 04/25/2024 at 11:00 a.m. of Staff A, RN performing CVC initiation and care of exit site for Patient #9 at station #3. Staff A, RN performed the care using the technique as above, glove-to-glove changes without hand sanitizing. An observation was performed on 04/25/2024 at 11:15 a.m. of Staff A, RN assisting with Patient #10 at station #2. Staff A placed the sterile supplies on the side table without a barrier in place. Staff A also assessed the cannulation site with a steth9oscope without cleaning it between patients. During an interview on 04/26/2024 at 1:55 p.m. Staff Q, Director of Nursing and Facility Administrator stated that per policy (which she read from) the staff was to perform hand sanitizing before and after touching a patient. Prior to entering and on exiting station to provide care to patient. Prior to contact with vascular access site. Prior to adjusting or removing cannulation needles. Before medication preparation. Before clean/aseptic procedure. After body fluid exposure risk. After touching patient surroundings. After gloves are removed. Before and after touching PPE. After contact with inanimate objects, including medical equipment or environmental surfaces at the patient station. Before entering and on exiting the patient treatment areas. When moving from a contaminated body site to a clean body site of the same patient. After handling biohazardous waste. She stated the staff was supposed to perform hand sanitizing between glove changes. She stated that gloves were not to be worn across the floor outside the patient’s station. She stated the drape had been contaminated after the dirty gauze was laid on the drape. Review of the facility’s policy, “Hand Hygiene,” revised on 08/2020 showed the purpose was to give guidance on proper hand hygiene and avoid the transmission of harmful germs and prevent healthcare-associated infections. Hand Hygiene will be performed: 1. Before and after touching a patient. 2. Prior to entering and on exiting station to provide care to patient. 3. Prior to contact with vascular access site. 4. Prior to adjusting or removing cannulation needles. 5. Before medication preparation. 6. Before clean/aseptic procedure (e.g. vascular access cannulation/decannulation, catheter care or administration of parenteral medications). 7. After body fluid exposure risk. 8. After touching patient surroundings (e.g. dialysis machine, any items in the dialysis are or chairside computers). 9. After gloves are removed. 10. Before and after touching PPE. 11. After contact with inanimate objects, including medical equipment or environmental surfaces at the patient station. 12. Before entering and on exiting the patient treatment areas. 13. When moving from a contaminated body site to a clean body site of the same patient. 14. After handling biohazardous waste. 20536 4. On 4/25/2024 at 10:27 a.m. a Personal Care Technician (PCT) Staff S was observed wearing a white fabric gown and also wearing a face mask and a face shield for infection control practices. He was observed at station #2 cleaning the chair and Dialysis machine with what appeared to be bleach wipes. Staff S then walked over to a supply cabinet approximately twenty feet from station #2, and opened a cabinet door which was above the clean sink, and took out supplies. Staff S then walked over to station #4, touched the chair back and then walked back to station #2. During the entire observation, he was observed to walk from station to sink/cabinet, then to another station and then back to the original station and never removed gloves, washed/sanitized hands or re gloved in between or after equipment and chair contact. Interview with Staff S confirmed he has been trained on handwashing procedures as well as gloving procedures between and after patient and patient care equipment contact. He confirmed he did not re glove and wash or sanitize his hands between and after equipment contact. 5. On 4/25/2024 at 10:43 a.m. a PCT Staff N was observed walking from station #11, with a patient to the front door. Staff N was observed touching the back left shoulder of the patient, while wearing his original gloves from when he was at station #11. He then walked back to station #11 from the front entrance door near the weight station and proceeded to cleanse the chair with a bleach wipe. Staff N never changed his gloves nor washed/sanitized his hands between and after patient contact. He only changed his gloves and sanitized his hands after he was finished wiping down the seat at station #11 approximately four minutes after he had contact with the patient. 6. On 4/25/2024 at 10:46 a.m. a PCT Staff N was observed to leave station #12 ungloved and walked to the clean sink/cabinet area and open a cabinet door and removed supplies from the cabinet. This sink and cabinet area was on the other side of the room approximately 20 - 25 feet away from station #12. He then brought the supplies back to station #12 and assisted to set up the supplies to the patient seated at station #12. Staff N was observed to not re glove and or wash/sanitize his hands between patient and equipment contact, and only re gloved after he finished assisting with patient set up at 10:49 a.m. Interview with Staff N confirmed that gloves should be removed prior to leaving the station, and hands should either be washed or sanitized prior to re gloving. Staff N could not remember if he removed his gloves and washed his hands between and after patient station equipment contact. 7. On 4/25/2024 at 11:00 a.m. station #13 chair was observed with both the plastic seat and both armrests cracked and torn. The areas were torn and cracked in a manner that was un cleanable. Also, station #1 chair was observed with what appeared to be approximately eight inches by eight inches towel taped on all sides. The white towel portion was observed soiled. It was unknown of why this towel area was taped. There had been patients seated in both chairs on this day 4/25/2024 shift. 8. On 4/25/2024 at 11:24 a.m. both PCT Staff S and Licensed Practical Nurse (LPN) Staff I were observed assisting a patient from a stretcher near the lobby door and the weight station. The patient was assisted into a chair and then they placed him on the weight machine, got a weight, and then proceeded to assist him to station chair #5. At 11:28 a.m. Staff I asked Staff S to assist and take the patient back to the weight station and get a re weight. While pushing the patient in his chair to the weigh station, Staff S was observed with his right hand ungloved and his left hand was gloved. Staff S took a black in color personal electronic phone device out form his right pant pocket brought it out through his white fabric gown and looked at it while transporting the patient to the weight scale. As soon as he got to the weight station, he then put the electronic phone device back in his pocket, while with his right hand still ungloved. Staff S weighed the patient, while touching the patient on his shoulder and brought him back to station #5. After Staff S repositioned the patient, he then re gloved his right hand. He did not however wash or sanitize his hand prior, between or after patient or electronic phone device contact. He also did not change his left hand glove after patient and equipment contact.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 28028 Based on review of medical records and staff interview it was determined the facility failed to ensure the interdisciplinary team provided medication, as ordered by the physician, to ensure patient’s hemoglobin/hematocrit level was achieved and sustained for three (#2, #5, #6) of ten patients sampled. Findings included: Review of the medical record for patient #5 revealed the interdisciplinary team (IDT) completed a plan of care for the patient on 3/29/2024. Review of the plan of care revealed the IDT identified the anemia goal was for a Hemoglobin level of 10-11.5 g/dL and it was not being met. The actions were to place the patient on the anemia management protocol, adjust as necessary per the physician ordered protocol, and monitor laboratory results to achieve the goal. Review of patient #5’s laboratory results revealed the patient’s hemoglobin (HGB) was monitored weekly. The results were as follows: 3/14/2024 HGB 9.2 g/dL, 3/21/2024 HGB 10.1 g/dL, 4/04/2024 HGB 9.4 g/dL, 4/11/2024 HGB 8.7 g/dL, 4/13/2024 HGB 9.1 g/dL, and 4/18/2024 HGB 8.6 g/dL. Review of the patient’s iron saturation laboratory results revealed on 2/01/2024 iron saturation 24 percent, on 3/07/2024 iron saturation 21 percent, and on 4/04/2024 iron saturation 14 percent. The goal of iron saturation is >20 percent. Review of physician’s orders for patient #5 revealed Venofer (medication used for iron deficiency anemia) was increased from 50 milligrams (mg) to 100 mg on 4/06/2024. Review of the patient flowsheet dated 4/13/2024 the Registered Nurse (RN) documented the Venofer was not administered with the note, “not given due to medication not available.” Review of the patient flowsheet dated 4/16/2024 the RN documented the Venofer was not administered with the note, “not given due to medication not available.” Review of the patient flowsheet dated 4/20/2024 the RN documented the Venofer was not administered with the note, “not given due to medication not available.” An interview was conducted with the Administrator/Director of Nursing (Staff Q) on 04/26/2024 at 1:55 PM. She confirmed the RN must document the physician was notified the medication was not administered as ordered. She stated the medication was on backorder and was not available at that time. 34768 Patient #6 was admitted on 02/19/2024. Diagnoses included but not limited to End-Stage Renal Disease, diabetes, and anemia. Physician orders showed Venofer 100 milligrams / 5 milliliter every treatment during dialysis was ordered on 03/28/2024. Record review of the following Hemodialysis Flowsheets dated 04/22/2024, 04/19/2024, 04/17/2024, 04/15/2024, 04/12/2024 showed “Venofer 100 mg/5 ml, every treatment-***NOT GIVEN DUE TO Medication Not Available***” Record review of the MD Comprehensive Monthly Note dated 04/17/2024 showed Anemia management protocol in use. Patient #2 was admitted on 11/24/2023. Diagnoses included but not limited to End-Stage Renal Disease and anemia. Physician orders showed Venofer 100 milligrams / 5 milliliter every treatment during dialysis was ordered on 02/16/2024. Record review of the following Hemodialysis Flowsheets dated 04/17/2024,04/15/2024, 04/12/2024 showed “Venofer 100 mg/5 ml, every treatment-***NOT GIVEN DUE TO Medication Not Available***” During an interview on 04/26/2024 at 1;55 p.m. Staff Q, the Director of Nursing and Facility Administrator stated there should have been a nurses note documenting the physician was notified the medication was not available and when to reschedule for the next treatment. Staff Q stated the medication had been on backorder. During an interview on 04/26/2024 at 1:55 p.m. Staff V, Regional Clinical Specialist verified with record review and stated that Patient #6 did not receive her Venofer on 04/12/24, 04/15/24, 04/17/24, 04/19/24, or 04/22/2024 or 5 doses. She stated that the nurse had not documented they had informed the physician that the medication was not given. During an interview on 04/26/2024 at 1:55 p.m. Staff V, Regional Clinical Specialist verified with record review and stated that Patient #2 did not receive his Venofer on 04/12/24, 04/15/24, 04/17/24, 04/19/24 or 4 doses. She stated that the nurse had not documented they had informed the physician that the medication was not given. During an interview on 04/26/2024 at 1:55 p.m. Staff W, Clinical Specialist stated that she had performed an audit at the facility on February 6, 2024, and found adequate documentation was not being performed. She stated it was still in the audit phase, no education had been performed yet. She stated she had returned this week to perform a 60-day follow-up and put a performance improvement plan in place related to documentation.”