Davita Lake Vista Dialysis

“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: 49691 Based on facility policy, observations and interviews the facility failed to ensure that staff adhere to hand hygiene standard practices to prevent possible cross contaminations of microorganisms in one (Staff F, Certified Clinical Hemodialysis Technician (CCHT)) of six staff members observed. Findings included: Reviewed the policy titled, “Infection Control for Dialysis Facilities”, # 1-05-01, revision April 2023 showed: Purpose- to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment ...1. All teammates, physicians, and non-physicians (NPP) will perform hand hygiene A. upon entering and existing the patient treatment area, B. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious materials, D. after patient and dialysis delivery system contact, e. after interaction with all boxes, F. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/ mouse ...The facility Medical Director and the Quality Improvement Committee will be made aware of infection control issues ... Disposable gloves will be worn when caring for the patient or touching the patients equipment at the dialysis station,...A. Gloves should be changed when: i. when soiled with blood, dialysate or other body fluids ii. When going from a “dirty” area to a “clean” area or task iii. when moving from a contaminated body site to a clean body site of the same patient. On 03/10/2025 at 10:14 AM Staff F, CCHT applied gloves and palpated (examine by touch) an AV fistula (Arteriovenous Fistula- An abnormal connection between an artery and a vein to make it possible to receive hemodialysis). After palpating the dialysis site, she applied antiseptic to Patient #11. She inserted the needle cannula with no hand hygiene or change of gloves between steps. Staff F, CCHT took Patient #11’s lab specimen to the lab area. She removed her gloves. No hand hygiene was performed. Staff F, CCHT went to computer #3 to document. She went to the computer at station #4 with Patient #13, changed gloves and withdrew blood from dialysis site. There were numerous missed opportunities of hand hygiene and glove changes. During a discussion on 03/10/2025 at 10:26 AM with Staff M, RN (Registered Nurse) regarding Staff F, CCHT missed opportunities to do hand hygiene and glove changes. She stated, “I will talk with her.” During an interview on 03/10/2025 at 10:53 AM with Staff T, Manager Clinical Specialist (MCS). Regarding the hand hygiene and she stated, “I don’t understand she is one of the better ones here.””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 49691 Based on policy, patient schedules, observation and interviews, the facility failed to minimize the possible spread of bloodborne pathogens by not observing proper cleaning and disinfection of dialysis stations in one (03/11/2025) of two days observed. Findings included: Reviewed the policy and procedure, “Infection Control for Dialysis Facilities”, # 1-05-01, revision: April 2023... Disinfection 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area ...13. At the end of each treatment containing cleaning station will be cleaned and disinfected. A. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g. dialysis chair, tray tales, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g. control panel; top, front, and sides of dialysis machines; touchscreens; countertops ...Facility hygiene 16. Clean area should be clearly designed for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated area where used supplies and equipment are handled. On Tuesday 03/11/2025 at 9:01 AM, Patient #4’s belongings bag was noted on the counter behind the dialysis recliner at station #23. Patient #4 had been dialyzed on Monday 03/10/2025 on the 2nd shift at approximately 9:15AM - 3:15P M at station #23. On Monday 03/10/2025 on the 3rd shift (aprroximately 2:30 PM - 7:15 PM), Patient #16 received dialysis treatment at station #23. On Tuesday 03/11/2025 at 9:05 AM, Patient #17’s belongings were in a backpack on the counter behind the dialysis recliner at station #17. Patient #17 dialyzed Saturday 03/08/2025 on the 1st shift (approximately 6:00 AM to 10:45 AM). Patient #20 dialyzed on the 2nd shift (approximately 9:15 AM to 3:15 PM). On Monday 03/10/2025, Patient #18 dialyzed on the 1st shift (approximately 6:00 AM to 10:45 AM). Patient #2 dialyzed on the 2nd shiftapproximately 9:15 AM to 3:15 PM). Patient #19 dialyzed on the 3rd shift(aprroximately 2:30 PM - 7:15 PM). All were on station #17 with the backpack on the back of the counter. On 03/11/2025 at 10:13 AM, Staff J, Patient Care Technician (PCT) observed cleaning station #20 and removing blood lines. She finished at 10:22 AM without disinfecting the counter where the patient on station #20 put his belongings. During an interview on 03/11/2025 at 9:10 AM with Staff S, FA (Facility Administrator) regarding patient belongings left at the dialysis station. She stated, “the staff is to take it to the Administrative Assistant, and she will keep it until they return their next dialysis treatment”. During an interview on 03/11/2025 at 10:23 AM with Staff J, PCT regarding disinfecting of station #20. She stated, “I was unaware that he set his belongings on the counter”. During an interview on 03/11/2025 at 10:55 AM, Staff T, MCS (Manager Clinical Specialist) stated, “I will let the staff know that if the patient sets their belongings on the counter, then to disinfect the counter.” Photo evidence obtained”

“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: 49691 Based on facility policy, observations, interviews and CDC (Center for Disease Control), the facility failed to ensure that clean supplies/equipment was not stored or located with dirty supplies/equipment in two days (03/10/2025- 03/11/2025) out of two days observed. Findings included: Review of the policy and procedures titled, “”Infection Control for Dialysis Facilities”, # 1-05-01, revision: April 2023. Purpose to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment ... Disinfection 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/ designated area or removal from treatment area ...13. At the end of each treatment containing cleaning station will be cleaned and disinfected. A. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with eh patient or their belongings (e.g. dialysis chair, tray tales, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g. control panel; top, front, and sides of dialysis machines; touchscreens; countertops ...Facility hygiene 16. Clean area should be clearly designed for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated area where used supplies and equipment are handled. On 03/10/2025 at approximately 8:45 AM during the flash tour, there were several corrugated boxes of varied supplies on and in several patient areas throughout the unit and dialysis stations. These boxes were from the original manufacturer. Concurrent with the tour, Staff T, Manager Clinical Specialist (MCS) and the Facility Administrator stated that these items should not be placed in patient, dialysis stations as they are considered “unclean”. They immediately removed them and obtained clear plastic containers in order to transfer these products from their original boxes for use into the unit. On 03/10/2025 at 12:46 PM, a tour was conducted on the dialysis floor and the laboratory specimen area noting blood collection tubes having patient initials and blood inside on the counter next to the spinner ( testing equipment). Clean, unused supplies were noted on the counter in between the blood specimens and dirty sink. On 03/11/2025 at 8:15 AM, a tour was conducted on the dialysis floor and an unused oxygen concentrator (uncovered) was noted at station #23 where on 03/10/2025 Patient # 4 utilized it. The tour continued with Patient #21 sitting at station #2 where an unused uncovered oxygen concentrator was seen. The 3rd oxygen concentrator is not being utilized but observed at station #17 with the station set up for a patient. On 03/11/2025 at 8:27 AM, behind the Administrative Assistant (AA) door which opens into the dialysis unit revealed clean equipment and patients’ equipment (wheelchair legs and bag), and the lobby door entrance into the dialysis unit revealed two trash cans beside the clean equipment. On 3/11/2025 at approximately 9:10 AM, corrugated boxes containing supplies were noted in the Isolation room, and on a supply cart near a patient dialysis station. During a discussion on 03/10/2025 at 1:30 PM, Staff T Manager Clinical Specialist (MCS) was shown the photos of the above and stated, “I see clean with dirty”. During a discussion on 03/11/2025 at 8:27 AM with Staff S, Facility administrator (FA) about the equipment behind the AA door, she stated “the wheelchair legs and bag belong to patients with the other is clean equipment”. During an interview on 03/11/2025 at 9:12 AM with Staff G, LPN (Licensed Practical Nurse) regarding the oxygen concentrators, he saif that the oxygen concentrators should not be at the dialysis stations because they are not being used by the patient. He also disclosed that they should have been cleaned and removed from the station after use. Review of the CDC (Center for Disease Control and Prevention) MMWR (Mobidity and Mortality Weekly Report) “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients dated April 27, 2001 Page 22, states “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.” Photographic 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: 49691 Based on facility policies, observations and interviews, the facility failed to ensure the equipment brought into the patient station area was disinfected after the patient completed treatment and left the facility in one (03/11/2025) of two days (03/10/2025- 03/11/2025) observed. Findings included: Reviewed the policy and procedures titled, “”Infection Control for Dialysis Facilities”, # 1-05-01, revision: April 2023 showed the Purpose is to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment ... Disinfection 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/ designated area or removal from treatment area ...13. At the end of each treatment containing cleaning station will be cleaned and disinfected. A. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g. dialysis chair, tray tales, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g. control panel; top, front, and sides of dialysis machines; touchscreens; countertops ... On 03/11/2025 at 8:15 AM, a tour was conducted on the dialysis floor and an unused oxygen concentrator (uncovered) was noted at station #23 where on 03/10/2025 Patient # 4 utilized it. The tour continued with Patient #21 sitting at station #2 where an unused uncovered oxygen concentrator was seen. The 3rd oxygen concentrator is not being utilized but observed at station #17 with the station set up for a patient. During an interview on 03/11/2025 at 9:12 AM with Staff G, LPN regarding the oxygen concentrators, he stated that the oxygen concentrators should not be at the dialysis stations because they are not being used by the patient. He also disclosed that they should have been cleaned and removed from the station after use. Photographic evidence obtained”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 49691 Based on policies, interviews and facility water logs, the facility failed to collect water sampling for cultures prior to disinfection of the water treatment system and dialysis machines. Failing to collect water samples prior to disinfection can put patients at a higher risk for infections. Findings included: Review of the facility policy, Water Culture Policy # 1-19-01, last revised April 2024 showed ...Purpose- To provide guidance to reflect that water used to prepare dialysate and dilute concentrates meets or exceeds current [facility name] standards ...Routine water cultures are collected monthly and within 72 hours prior to scheduled disinfection of distribution systems. Review of the facility policy, Water Treatment System Disinfection, Policy: 1-16-01, last revised 10/2021 showed ...PURPOSE: To disinfect Reverse Osmosis (RO) devices and the distribution system on a regular basis and in response to elevated bacteria and/or endotoxin test results. Review of the reverse osmosis log showed disinfection of the facility machines on Tuesday, 3/4/25 3:35 PM with initials. During an interview with the facility Biomed Technician (BT) on 3/10/2025 at approximately 1:00 PM regarding collecting water sample and disinfection of the water treatment system, the BT said he collects the water samples for culture the day prior to the disinfection on Thursday. This surveyor noted the discrepancy in the logs stating that disinfection was completed on Tuesday and the BT stated he was not made aware of the change in days. During an interview with Staff T, Manager and Staff F, Patient Care Technician (PCT) on 3/10/2025 at approximately 1:30PM, they stated that the change was made to a different day because “ Tuesdays are less busy”. Staff F, PCT said the decision to change the day of the week was made by “me and the facility administrator” and that the Biomed Technician had not been notified.”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must include, but not be limited to, an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors. This Standard is not met as evidenced by: 49691 Based on policies, record review and interviews, the facility failed to include water quality, sampling and disinfection in the quality assurance and performance improvement discussions and improvement plans as necessary in 1 of 1 QAPI plan. Failure to include all safety aspects of quality in dialysis can lead to an increase in adverse outcomes. Findings included: Review of the facility policy titled Water Culture Policy, 1-19-01, last revised April 2024, stated ... The Facility Administrator or designee is responsible for verifying that cultures are obtained, results recorded, reviewed and necessary actions taken, as applicable ... Results and trends are reviewed during the Facility Health Meeting (FHM) and documented in the meeting minutes. Review of the of the FHM (Facility Health Meeting) minutes dated September 2024, showed “BioMed report - N/A” Review of the of the FHM (Facility Health Meeting) minutes dated November 2024, shows BioMed report - ...RO [Reverse Osmosis - systems for purifying water used in hemodialysis by removing contaminants and ensuring safe, high-quality water for dialysis treatments.) - weekly disinfection initiation time not documented ... Review of the of the FHM (Facility Health Meeting) minutes dated December 2024, shows “BioMed report -. “ No further data is listed. Review of the of the FHM (Facility Health Meeting) minutes dated January 2025, shows 1/2/25 RO Weekly Chemical Disinfection Not Completed Review of the reverse osmosis log showed disinfection of the facility machines on Tuesday, 3/4/25 3:35 PM with staff initials. During an interview with the facility Biomed Technician (BT) on 3/10/2025 at approximately 1:00 PM regarding collecting water sample and disinfection of the water treatment system, the BT said he collects the water samples for culture the day prior to the disinfection on Thursday. This surveyor noted the discrepancy in the logs stating that disinfection was completed on Tuesday and the BT stated he was not made aware of the change in days. During an interview with Staff T, Manager and Staff F, Patient Care Technician (PCT) on 3/10/2025 at approximately 1:30PM, they stated that the change was made to a different day because “ Tuesdays are less busy”. Staff F, PCT said the decision to change the day of the week was made by “me and the facility administrator” and that the Biomed Technician had not been notified.”

“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: 49691 Based on facility documents and interviews, the facility failed to ensure patient mortality was analyzed extensively to identify potential cause of death and implement actions to improve performance throughout the facility in four (September, November, December and January) out of four months of data provided. Findings included: Review of the Facility Health Meeting minutes revealed that in 4 months there were 12 mortalities. During an interview on 03/11/2025 at 11:47 AM with Staff S, Facility Administrator regarding mortalities, she stated, “We discuss it, and the doctor would know more about it, because he can see the medical record at the hospital. We do not go into in-depth review.””

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 49691 Based on policies, observations, facility audits, and interviews conducted, the facility failed to identify trends to reduce the possibility of bloodborne pathogens transmission in 1 of 1 Quality Assurance Program Improvement (QAPI) program. Finding included: Review of the policy, “Infection Control for Dialysis Facilities”, # 1-05-01, revision: April 2023 states the purpose is to minimize the spread of infections or bloodborne pathogens in the dialysis facility environment ...1. All teammates, physicians, and non-physicians (NPP) will perform hand hygiene a. upon entering and existing the patient treatment area, B. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious materials, D. after patient and dialysis delivery system contact, e. after interaction with all boxes, F. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/ mouse ...The facility Medical Director and the Quality Improvement Committee will be made aware of infection control issues ... On 03/10/2025 at 10:14 AM Staff F, Certified Clinical Hemodialysis technician (CCHT) applied gloves and palpated (examine by touch) an AV fistula (Arteriovenous Fistula- An abnormal connection between an artery and a vein to make it possible to receive hemodialysis). After palpating the dialysis site, she applied antiseptic to Patient #11. She inserted the needle cannula with no hand hygiene or change of gloves between steps. Staff F, CCHT took Patient #11’s lab specimen to the lab area. She removed gloves. No hand hygiene was performed. Staff F, CCHT went to computer # 3 to document. She went to the computer at station #4 with Patient #13, changed gloves and withdrew blood from dialysis site. There were numerous missed opportunities of hand hygiene and glove changes. Reviewed the facility audits for three months (September 2024,January 2025, March 2025) revealed that no hand hygiene was performed after removing gloves and describe any missed attempts- needs more handwashing. No staff member identified on the audits to identify trends. During a discussion on 03/10/2025 at 10:21 AM with Staff M, Clinical Coordinator regarding audits, she stated “the audits only have an area for disciplines (job title) not the staff initials, so I do not know which staff I audited last time”. During an interview on 03/11/2025 at 11:27 AM with Staff S, Facility Administrator regarding lack of hand hygiene, she stated “I had not received any reoccurring names of the offenders from the audits.””

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 49691 Based on policies, facility job description, observation and interview, facility failed to ensure the staff worked within their scope of practice in two (Staff C, Certified Clinical Hemodialysis Technician (CCHT) and Staff E, CCHT) of six staff observed. Findings included: Review of the policy and procedures titled, “Medication Policy”, # 1-06-0, revision October 2023...Notes: All nurses must be licensed by the state in which they are practicing. The scope of practice and other statutes, rules and regulations that impact the practice of RN, LPN and PCT may vary among states ...Heparin [an anticoagulant, used to decrease the clotting ability of the blood and help prevent harmful clots from forming in blood vessels], lidocaine [local anesthetics,which prevents pain by blocking the signals at the nerve endings in the skin], and normal saline [a sterile, intravenous fluid solution containing 0.9% sodium chloride (NaCl) in water] may be drawn up and administered by licensed nurse teammates and Patient care technicians if allowable by their state and they have met their state’s educational requirements ... Reviewed the Job description “Patient Care Associate ICHD (In- Center Hemodialysis) Resident” date 04/2023... The patient care associate position assists registered nurses and patient care technicians and providing dialysis treatment for the end stage kidney disease patient in accordance with federal state and local regulations... Review of the Personnel worksheet provided by the facility, revealed Staff, C and Staff E as “PCT” (Patient Care Techinican). On 03/10/2025 at 9:38 AM Staff E, Certified Clinical Hemodialysis Technician (CCHT) also known as a PCT, discontinued treatment to a Central Venous Catheter on Patient #3 and attached syringes of heparin to both ports and called Staff M, Clinical Coordinator to administer the medication. On 03/10/2025 at 10:32 AM Staff C, CCHT/PCT attached a syringe of heparin to Patient #14 dialysis line port for Staff L, RN (Registered Nurse) to administer the mediations. During a discussion on 03/10/2025 at 9:45 AM with Staff E, CCHT in regard to the heparin syringe being attached to dialysis port, she stated, “We are allowed to do this”. During an interview on 03/10/2025 at 10:55 AM, Staff S, Facility Administrator stated “Yes, the CCHT can do the Heparin”. During an interview on 03/10/2025 at 11:20 AM, Staff S, Facility Administrator stated, “I found out that technicians cannot attach the heparin”. Photo evidence obtained.”