Rosedale Kidney Disease Center

“CFC-PERSONNEL QUALIFICATIONS CFR(s): 494.140 This Condition is not met as evidenced by: 34839 Based on employee file review and staff interviews, the facility failed to maintain current documentation to demonstrate personnel met the basic requirements of their assigned roles. Specifically, the facility failed to provide evidence that facility float pool staff members: 1. demonstrated annual skills and competency training for 3 out of 3 facility float pool staff members. 2. received specific dialysis machine training for 3 out of 3 facility float pool staff members. 3. demonstrated in center Hemodialysis Training for 1 out of 3 facility float pool staff members. Refer to tag V681 for specific evidence.”

“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: 34839 Based on staff file review and staff interview, the facility failed to ensure that staff met personnel qualifications and demonstrated competencies before providing dialysis treatment. The dialysis facility staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. Specifically the facility failed to provide evidence that facility float pool staff members: 1. demonstrated annual skills and competency training for 3 out of 3 facility float pool staff members. 2. received specific dialysis machine training for 3 out of 3 facility float pool staff members. 3. demonstrated in center Hemodialysis Training for 1 out of 3 facility float pool staff members. The findings included: 1. Review of staff files revealed 3 of 3 facility float pool (Personnel #1, #2, and #3) lacked evidence of staff annual skills check off prior to providing patient care in the facility. 3 of 3 facility float pool staff files (Personnel #1, #2, and #3) reviewed did not contain current in center hemodialysis competency skills checklists and competency skills. Annual Clinical Exam for Texas ONLY Personnel #3 Outpatient RN CAP 1 Has successfully completed this course on 02-01-2024 Personnel #2: No skills checklist or skills competency available in staff file. Annual Clinical Exam for Texas ONLY Personnel #1 Home Therapies RN CAP 3 Has successfully completed this course on 09-26-2023 Annual Clinical Skills Validation for RNs Personnel #1 Home Therapies RN CAP 3 Has successfully completed this course on 03-15-2024 Interview with Director of Operations Staff #3 on 4/22/24 at 0952 stated, “We’re going to have to look at changes to our process.” Surveyors asked, as a manager would you want to see all of a staff members training. Director of Operations Staff #3 stated on 4/22/24 at 0954 “Yes.” Surveyors continued questioning that managers are currently not able to see all of staff members training, Director of Operations Staff #3 stated, “Correct. Only what’s uploaded, or if I have the visual file in front of me.” 2. Review of staff files revealed 3 of 3 facility float pool (Personnel #1, #2, and #3) lacked evidence of specific facility dialysis machine training. Surveyors questioned Staff #5 on 4/17/24 from 1251 to 1256. Surveyors questioned where on the staff training does it specify what specific dialysis machine staff are trained on. Facility Senior Manager of Clinical Education stated “The first thing it asks is what machine you’re skilling on.” Regarding the LMS (Learning Management System) Course printout. “ It doesn’t necessarily give all the details.” Interview continued on 4/22/24, facility Senior Manager of Clinical Education stated at 1054, “It’s a process that there’s a place to put it, it’s just not coming out.” 3. Review of staff files revealed 1 of 3 facility float pool (Personnel #1) lacked evidence of training as an in center Hemodialysis nurse. Annual Clinical Exam for Texas ONLY Personnel #1 Home Therapies RN CAP 3 Has successfully completed this course on 09-26-2023 Annual Clinical Skills Validation for RNs Personnel #1 Home Therapies RN CAP 3 Has successfully completed this course on 03-15-2024 Surveyors questioned facility Senior Manager of Clinical Education on 4/17/24 from 1251 to 1256. Facility Senior Manager of Clinical Education stated regarding staff LMS (Learning Management System) training for skills and competency. “They combined it into one. That started in 2024. You see that as a certificate whichever is specific to their title.” Surveyors continued questioning if a staff member has a title such as home therapies, what would be their scope of training. Facility Senior Manager of Clinical Education stated “It’s Home Therapy. It says it’s under the discipline they’re titled under.” Interview with Director of Operations Staff #2 on 4/22/24 at 0951 regarding showing the specific skills the preceptor tests facility staff members on; stated, “We cannot view their LMS.” Interview with Director of Operations Staff #3 regarding the surveyor findings regarding the 3 facility float pool staff stated on 4/22/24 at 1101 “Absolutely we own it. It’s just a broken process.””

“CFC-COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 This Condition is not met as evidenced by: 34839 Based on observation, interviews and documentation reviewed, the facility is not in compliance with applicable State regulatory licensing requirements. Specifically, A.) The facility failed to report to the department (Texas Department of Health and Human Services Commission) TX HHSC the patient deaths for 18 dialysis patients and emergency hospital transfers for 12 dialysis patients reviewed from 1-2023 to 2-2024 that had not been reported within the 10 working days in accordance with State law, B.) The facility failed to test the conductivity with an independent meter prior to initiation of treatment, and C.) The facility failed to provide adequate staffing to meet the patient needs when the Charge Nurse(CN) was observed providing direct patient care duties contrary to Texas ESRD Rules and Regulations. Refer to tag V101, for specific evidence. As a result, the facility was not in compliance with CFC for Compliance with Federal/State/Local Laws”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 34839 Based on observation, record review, and staff interview, the facility staff failed to A. ensure a clean and sanitary environment was monitored and maintained in the patient lobby, in-center treatment area, and supply room. The facility staff failed to follow the facility’s policy titled, “General Cleanliness and Infection Control Guidelines”. (Cross Reference Tag V0111) B. ensure all staff labeled and dated the bleach containers that were used for cleaning and disinfecting non-disposable equipment. The facility failed to follow its policy titled, “Cleaning and Disinfection of the Dialysis Station.” (Cross Reference Tag V0122) These deficient practice have the likelihood to result in the transmission of infectious agents within the unit and between patients, staff members, and members of the public affecting patient safety. As a result, the facility was not in compliance with the CFC for Infection Control”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 34839 Based on observation, review of documentation and interview, it was determined that the physical environment was not maintained to ensure the safety of staff and patients. Specifically, 1.) the facility failed to provide a surface that can be disinfected for the 20 stations inside the dialysis facility. The splash zones in each station had chips of dry wall exposed with dried blood, bugs and debris on 20 of the 20 stations. 2.) the facility failed to provide proper labeling of bleach water. 3. the facility failed to maintain a comfortable sanitary environment. The facility wall boxes had heavy build up of acid crystals dust dirt and blood. Floors were chipped, dirty and debris observed throughout the facility Refer to V tag: V401 for specific evidence. These deficient practices placed all 86 patients at the facility at risk of infection and/or cross contamination. As a result, the facility was not in compliance with the CFC for Physical Environment.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 21863 Based on record review and interview, the facility failed to develop, implement, maintain, and evaluate an effective data-driven quality assessment and performance improvement program and to analyze, track, trend, and develop appropriate action and follow up as required to improve health outcomes, the prevention of infections, the reduction of medical errors and adverse events. Specifically, the facility’s Quality Assessment and Performance Improvement Committee (QAPI) failed to: A. Ensure the facility had a dedicated Infection Control reporting program in which staff identified, tracked and trended infections in the facility; and B. Ensure a thorough review of the patient mortalities to allow for identification, prevention and reduction of mortality and morbidities by developing an action plan to prevent and/or decrease mortality events; and C. Provide evidence of the facility’s QAPI Meeting minutes that are conducted monthly. The last completed QAPI meeting minutes were from June 2023. These deficient practices placed all current 86 Hemodialysis patients receiving treatment by the facility staff at an increased risk of significant health infections, and errors leading up to and including the possibility of death by failing to reduce and prevent medical errors and adverse events. The cumulative effects of this deficient practice resulted in the facility’s inability to comply with the CFC for Quality Assessment and Performance Improvement. Refer to tags V626, and V111 for specific evidence.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 21863 Based on treatment area observations, review of governing body minutes, review of Quality Assessment and Performance Improvements (QAPI) meeting minutes, Governing Board Meeting minutes, Infection Control Audit Tools and facility staff interviews with the governing body, it was determined the dialysis facility failed to ensure the governing body enforced rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients and to the general operation of the facility. Specifically, the governing body failed to: A.) ensure an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients, See V757 for specific evidence B.) 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. CFR 494.30 CFC Infection Control not met. Refer to COP V110, V111 and V122 C.) ensure an effective QAPI program by developing, implementing, maintaining and evaluated an effective, data-driven, QAPI program, and that death mortality reviews were completed. CFR 494.110 CFC Quality Assessment & Performance Improvement not met. Refer to COP V625 and V626. D.) maintain a safe, functional, and comfortable treatment environment, CFR 494.60 CFC Physical Environment not met. Refer to COP V400 and V401 E.) ensure compliance with federal and state laws for reporting deaths and hospital transfers to Texas Department of Health and Human Services, CFR 494.20, CFC Compliance with Federal/State/Local Laws. Refer to COP V100 and V101. All 86 current facility patients are at risk to serious harm up to including death due to the dialysis facility failed to ensure the governing body enforced rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients and to the general operation of the facility. As a result, of the facility’s condition level non compliance with the following conditions cited: CFR 494.20 Compliance with Federal/State/Local Laws, CFR 494.30 Infection Control, CFR 494.60 Physical Environment, CFR 494.110 Quality Assessment & Performance Improvement, and CFR 494.180 Governance Review of the Governing Body Meeting minutes that are conducted quarterly revealed the last completed Meeting minutes were from January 23, 2023, and were incomplete. On 2/27/24, it was determined there was an Immediate Jeopardy risk to the patients health and safety.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 34839 Based on observation, interviews and documentation reviewed, the facility is not in compliance with applicable State regulatory licensing requirements and other relevant health and safety requirements. Specifically, A.) The facility failed to report to the department (Texas Department of Health and Human Services Commission)TX HHSC the patient deaths for 18 dialysis patients and emergency hospital transfers for 12 dialysis patients reviewed from 1-2023 to 2-2024 that had not been reported within the 10 working days in accordance with State law, B.) The facility failed to test the conductivity with an independent meter prior to initiation of treatment, and C.) The facility failed to provide adequate staffing to meet the patient needs when the Charge Nurse(CN) was observed providing direct patient care duties contrary to Texas ESRD Rules and Regulations. Findings included: A.) Mortality and Ambulance transfer. Review of the facility’s Patient death and emergency transfer list for 1/1/23 to 2/27/24 revealed the following: 18 deaths P#1 expired 11/11/23 P#2 expired 2/20/23 P#3 expired 1/8/24 P#4 expired 1/29/24 P#5 expired 6/10/23 P#6 expired 1/26/24 P#7 expired 11/15/23 P#8 expired 3/31/23 P#9 expired 9/28/23 P#10 expired 1/20/23 P#11 expired 4/26/23 P#12 expired 9/23/23 P#13 expired 8/12/23 P#14 expired 4/23/23 P#15 expired 3/25/23 P#16 expired 1/12/23 P#17 expired 6/21/23 P#18 expired 12/15/23 12 ambulance transfers. P#3 transfer 11/06/23 P#5 transfer 5/15/23 and 4/17/23 P#19 transfer 2/23/24 P#20 transfer 1/27/24 P#21 transfer 9/15/23 P#22 transfer 12/18/23 P#23 transfer 3/25/23 P#24 transfer 2/25/23 P#25 transfer 2/19/24 P#26 transfer 9/20/23 P#27 transfer 3/11/23 Surveyor requested all Texas HHSC Reports submitted for the last year, none were provided. Interview on 2/27/24 at 13:40 PM in the facility conference room with S#2, surveyor reiterated the request for all TX HHSC reports, S#1 stated “ I have not submitted any and I have not completed any mortality reviews, I don’t have the form”. Surveyor requested the policy on TX HHSC reporting for deaths and hospital transfers. S#9 stated, “We don’t have a policy, we are supposed to follow the state of Texas regulations.” B.) Testing the conductivity and PH (Potential hydrogen): Observations on 2/26/24 at 11:31 AM S#4 had to be redirected to test the machine conductivity and PH prior to initiating treatment. S#4 did NOT verify the results with a second staff member. Interview with S#4 stated “ I already did the test” Surveyor explained to S#4 that he changed the acid to a jug therefore additional testing is required. Texas Administration Code Rule, section 117.32(c)(3), Regulation 0069 of the Texas Department of State Health Services ASPEN Regulation Set reads in part: Water Treatment, Dialysate Concentrates, and Reuse. (c) Dialysate. (3) Prior to each patient treatment, staff shall verify the dialysate conductivity and pH of each machine with an independent device. Review of the facility Policy Titled Checking the Conductivity and PH, published 4/11/22 #25912 Version 9 reads in part: Policy Dialysate PH must be tested when changing acid concentrate formulations during treatment. Test Verification Prior to Treatment reads 2 staff members will verify the conductivity and PH parameters prior to treatment. C.) Adequate staffing Observations on 2/26/24 at 09:00 AM there were multiple machine alarms not being addressed S#8 stated “You start hearing it in your dreams at night”. Station #19 the machine alarm started at 09:20 am the Charge Nurse (CN)/Registered Nurse (RN) #10 checked the alarm at 09:24. Station#17 the machine alarm started at 09:20, the surveyor had to direct the facility CN/RN #10 to check the alarm at 09:26. Review of P#28 Treatment Sheet dated 2/26/24 Prior to treatment Blood Pressure ( BP ) was 221/118 06:38 BP 186/111 AM S#7 documented bp elevated asymp, feet lowered, will try to lower bp with UF. 06:55 BP 178/108 S#3 documented Denies complaints patient alert. 07:15 BP 178/102 S#3 documented Denies complaints patient alert. 07:37 BP 170/111 S#3 documented Denies complaints patient alert. 07:42 BP 169/102 S#3 documented Denies complaints patient alert. 07:55 S#7 documented 2nd clonidine given pt asymp. Will continue to monitor. 08:01 BP 156/61 S#3 documented Denies complaints patient alert. 08:23 BP 152/101 S#10 documented PCT reports pt c/o feeling nauseated and hot BP stable Zofran given BS checked is at 42mg/dl will give oral gel glucose and snacks at chairside Will recheck sugar in 15 min. 08:47 BP 166/109 S#11 documented Pt states she is fine alert and oriented. 09:15 BP 168/115 S#10 documented Denies complaints, treatment discontinued without problem patient request AMA due to feeling hot: BS is now at 82 mg/dl, risks reviewed. Review of the facility reportable parameters for 2024 states in part. RN to MD reporting: 1. During dialysis B/P High BP systolic > 180 after 1 hour of tx and clonidine administered or diastolic >110 after 1 hour of tx 2. Post Dialysis B/P high BP systolic >180 diastolic > 100. During an interview with CN/RN, S#10 on 2/26/24, Surveyor asked if the MD had been notified of the high BP. S#10 stated “It seems like we have a lot of call ins, and today was one of them, that’s why I haven’t had time to call the MD as needed. I’ve been running all over the place today.” Review of the staff/patient daily assignments for 2/1/24 - 2/26/24 , documentation revealed the RN who was also the CN and the Medication Nurse was assigned all nursing responsibilities for all patients that included initiation and termination of patients that have a central venous catheter (CVC) and fistulas as well as administration of all patient ordered medications, assessments, and other CN duties. Review of patient/staff assignments identified 1 CN, 1 Medication Nurse and 4 PCTs (patient care technicians) assigned to provide direct patient care to the facility’s patient census of 86, on the following dates: February 7th, 8th, 15th and 26th. Direct patient care includes initiation, termination of all patients with a CVC, administration of medications and charge nurse duties. Documentation of patient treatments have the CN signatures for patient care. In an interview on 2/26/24 at 2:30 PM with the Director of Operations confirmed CN/RN (staff #10) does provide direct patient care. Review of the Governing Body Policy published 07/03/2023 version 1 indicated, in part under “ General Responsibilities” Governing Body duties ( generally in conjunction with the Medical Director) include but not limited to: Ensuring adequate staff coverage. Maintaining compliance and adherence to federal healthcare program requirements/state regulations including staffing. Regarding short staffing the Director of Operations stated on 2/26/24 at 1526 “I was not notified today. A majority of the time I have not been notified.””

“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: 34839 Based on observation, record review, and staff interview, the facility staff failed to ensure a clean and sanitary environment was monitored and maintained to minimize the transmission of infectious agents in the patient lobby, in-center treatment area, supply room; and in accordance with the facility’s policy titled, “General Cleanliness and Infection Control Guidelines”. This deficient practice had the likelihood to result in the transmission of infectious agents within the unit and between patients, staff members, and members of the public. Findings included: During a tour of the facility on 02/26/2024 at 8:30 AM the following infection control issues were observed: 1.) Patient Lobby -Brown-stained ceiling tiles observed. - Identified 5 out of 8 chairs in the patient lobby were torn, frayed and holes noted on the seats and chair backs. -Chair rails had heavy build up of dust dirt and debris. -Corners and edges of the floor had heavy build up of dirt dust and black substance. - Windowsills had cobwebs dust dirt and dead bugs. -The vending machine had debris and a cup on the top. 2.) In-Center Treatment Area Observations were conducted on 2/26/2024 from 0900 to 0958, from 1100 to 1130, and from 1712 to 1732 revealed: -5 out of the 5 half walls in the treatment area had holes cracks dust and wear of the laminate as well as white splatters. -The walls were noted to be separating at the corners, and a piece of wood hanging off the wall under the chase box at station #14. -20 out of 20 chase boxes had heavy build up of dust dirt and white crystallized substance. -Wall boxes at stations #3, #7 #12, #13, #-14 and #18 had dried reddish-brown substance. -20 out of 20 dialysis inlet filters had dirt dust and debris in them. -20 of the 20 black wraps on the water lines from the back of the machine to the chase box were dirty dusty and had white crystal-like splatters on them. -Dried blood on the biohazard sharps container at station #10 at 0936 am and the same blood splatter noted at 1730 PM. -2 jugs of acid with uptake wands (with white crystal substance on the top) sitting on a clean counter with clean patient supplies. -Large black box sitting outside of the clinical manager office had heavy build up of dirt and dust. -20 out of 20 sharps containers were full or greater than ¾ full. -3 IV poles had dirty dusty and white splatters on the base. -Black utility cart with 2 shelves was dirty dusty and a heavy buildup of white splattered substance. On the top shelf had a blue plastic tray that had 15 “clean “bottles for end of day citric acid clean. The bottom shelf had a blue plastic tray that held the uptake wands for the citric acid bottles has a brown rust colored substance in the crevasses as well as splatters of white substance. -3 poles housing hand sanitizer and gloves were rusty, dusty, and dirty. -20 of the 20 blood pressure cuffs had heavy had fabric unknown debris affixed to the Velcro portion of the cuff. There was no way to know if the blood pressure cuffs had been disinfected. -1 Bucket/bin and 4 bottles containing a clear fluid had no labels to identify the contents. -Cracked and broken floor tiles throughout the facility. - Floors had trash, dirty gloves, heavy build up of dust, dirt and build up of black substance in the corners and along the edges of the baseboards. -2 windowsills had cobwebs, dust, dirt and dead bugs. -Stained ceiling tiles throughout the facility. -The patient lift was stored with the patient’s wheelchairs and personal items. The patient lift had been designated as clean. The lift was making direct contact with a patient’s wheelchair. -The wall molding located next to the wheelchair storage area was damaged and missing. There was no way for the staff to properly clean the wall due to the damage to the wall molding and raw wood being exposed. -A patient’s lunch box was found stored in the medication cabinet. -The gray trash cans and biohazard waste bins touching IV pole housing clean gloves and hand sanitizer between the patient stations had a white substance splashed on the side of them. The trash cans had not been cleaned by facility staff. 3.) Supply Room During a tour of the supply room on 02/26/2024 at 11:00 AM with Staff # 2 and # 4, the surveyor observed the epoxy floor of the supply room was chipping away and could not be properly cleaned and disinfected. Review of the facility’s monthly infection control (IC) audit tools for 1/3/24, 12/6/23, 11/2/23, 10/20/23 identified IC failures as documented: -gloves not changed per policy, -patients failed to perform hand hygiene when entering and exiting the treatment area, -Full PPE not worn by staff, visitors, transportation and physicians, -visible blood on surfaces, sharps, containers, chairs, wall, etc. -Murphy meter used and cleaned per P&P before and between each treatment. Review of the facility’s policy titled, General Cleanliness and Infection Control Guidelines, Published 02/07/2022 indicated, in part: All areas must be kept clean and organized, including but not limited to the treatment area, water/supply room, and offices. Walkways must be kept clear of debris and free of clutter. Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection. Eating, drinking, applying cosmetics or lip balm, and handling contact of lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets, or on countertops or bench tops where blood or other potentially infectious materials are present . 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. Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station . All containers for storage or disposal of needles/sharps shall be replaced on a regularly scheduled basis or when no more than 2/3 to 3/4 full. An interview with Staff #9 on 02/26/2024 at 17:30 PM confirmed the facility staff had not followed the facility’s policy, “General Cleanliness and Infection Control Guidelines” and had failed to maintain a sanitary environment in the patient lobby, in-center treatment room, and the supply room. Staff #9 stated, “ I am disappointed.” The Centers for Disease Control (CDC) defines a “sanitary environment” as an environment that meets the “Standard Precautions” for an inpatient hospital setting plus the more stringent precautions which are recommended for Hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms.”

“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: 34839 Based on observation and interview, the facility failed to ensure all staff labeled and dated the bleach containers that were used for cleaning and disinfecting non-disposable equipment. The facility staff failed to follow its policy titled, “Cleaning and Disinfection of the Dialysis Station.” This deficient practice has the likelihood of contaminating dialysis surfaces with a less effective bleach solution. Findings include: Observations of the treatment floor on 2/26/2024 from 09:00 AM to 09:58 AM revealed the surveyor observed blue bleach solution containers that were not dated or labeled with the 1:100 bleach solution. 4 Small pitchers were being used for the 1:100 bleach solutions and the pitchers were not labeled or dated.. There was another container containing numerous clamps. There was no label to determine if the clamps were clean or dirty. Also, there was no way to determine when the bleach solution was mixed due to no label on the container. The dialysis guideline for bleach solution was to be mixed every 24 hours in the dialysis setting. An interview with the S#4 on 02/26/2024 at 10:15 AM was asked where the label was for the bleach container. Staff #4 stated, “The label should be on the container.” The surveyor had to point out that there was no label and there was no date or clarification of the type of bleach solution. An interview with Staff # 8 on 02/26/2024 at 10:45 AM confirmed the bleach containers were not labeled with the type of bleach solution and there was no current date. There was no way to determine the date the bleach solution was mixed and the type of bleach solution. A review of the facility’s policy titled, “Cleaning and Disinfection of the Dialysis Station,” dated 09/2023 revealed the following: “Keep bleach solution in a location convenient to all dialysis machines/stations. Bleach solution will be stored in labeled, covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air. Bleach solution will be mixed in the appropriate dilution in accordance to the type of cleaning and disinfection required. When mixing bleach solutions, staff must wear PPE, including disposable gloves, face shield or eye protection with full side shields and fluid-resistant gowns. Refer to Mixing Bleach procedure.””

“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: 34839 Based on observation and interview, the facility failed to ensure the building was maintained to provide a safe, functional treatment environment for dialysis patients, staff, and the public. Specifically, the facility failed to ensure that the ceilings, walls, floors, cabinets, sinks, and equipment were clean, maintained, and free of potentially infectious materials throughout the facility. This deficient practice could affect all 86 Hemodialysis patients dialyzed in the facility by allowing for the cross-contamination of clean supplies and equipment possibly leading to blood borne illnesses and/or infections. Findings included: Observations were conducted on 2/26/2024 from 0900 to 0958, from 1100 to 1130, and from 1712 to 1732 revealed the following: -Small brown particles in clean supply drawer with clean patient dialyzers -Saline bag clean supply drawer with rusted metal rails, unable to close drawer fully. -Candy bar in clean supply drawer. -Clean supply under sink storage with brown and black small brown particles, large brown and yellow stains, dead spider, and bottle with clear liquid labeled H2Orange concentrate 117 Sanitizer/Virucide Cleaner half filled with clear liquid. This surveyor asked the Facility Administrator (FA) what is that bottle on 2/26/24 at 0926 “I’m not sure.” A picture of the bottle was shown to Area Biomedical Team Lead and he stated on 2/26/24 at 1715 “I don’t know what they (facility staff) put in it. We don’t use that degreaser.” -Drawer with clean machine dialysis lines with small black particles. -Drawer with clean syringes with small black particles. -3 staff roller chairs with white substance on plastic bases. 1 of 3 chairs with rusted metal pole. -2nd under sink storage large round brown stain and black small brown particles. -Under cabinet storage with 2 large brown stains, small black particles, and a dead bug. -Under cabinet storage with small brown stains, small brown particles and white cloth wipes with small brown particles on top of cloth wipes. -Under sink storage with large hole in the drywall around the plumbing fixtures, exposed insulation and large amount of black substance on the drywall. -Large opaque storage container filled with clear fluid labeled with only date, time and initials. -Staff glove cart with white substance on base and rusted metal pole. -Under cabinet storage containing clean saline bags with large brown stain and small brown particles. -Cart holding clean gloves and hand sanitizer the hand sanitizer plastic holder broken and held in place with tape, blood on outside of multiple sharps containers. -Patient lunch bag in facility cabinet for patient medication. -Blood on outside of sharps container at machine #5 at 0916, surveyors returned and same blood still on outside of sharps container at machine #5 at 1727. -Machine #10 Station #12 with new setup for patient with machine dialysis lines resting on sharps container that has splatter of blood on the outside of sharps container. -Station #12 with new dialysis lines and dialyzer set up for next patient; back of patient chair with dried bicarbonate. -Wall next to clean saline storage cabinet with peeling paint and small gap between wall and flooring trim. -Over cabinet storage with wadded blue medical gloves touching sterile non-woven sponge supplies. Staff goggles touching sterile non-woven sponge supplies. -Patient emergency evacuation box next to Clinical Manager’s office covered with large amount of white substance. -Patient medication station under cabinet storage with cabinet trim missing and peeling. -Under sink storage next to refrigerator labeled Nutritional Supplement Refrigerator with large brown stain, small brown stain and large amount of small and large black particles. -Patient lunch bag labeled with patient name in over counter storage at medication station next to patient nutrition bars. -5 IV poles in area labeled IV poles covered in white substance on black plastic bases. 3 of 5 IV poles with rusted metal poles. -Counter of station labeled Clean Sink with large amount of white substance on top. One staff face shield on top of counter. -Under counter storage at station labeled Clean Sink with approximately 6 staff face shields. -Gray cart with 5 jugs of unopened Naturalyte with large amount of white and brown substance on the surface of cart. -Gray cart labeled Bleach Cart with 13 disinfectant bottles containing yellowish fluid and 2 empty bottles inverted. -Cart with large amount of white substance covering the cart. -Black cart labeled citric acid cart with large clear jug filled with clear fluid. Black cart and large clear jug covered with large amount of white substance. Large clear jug does not have lid to cover. Interview with Staff #4 on 2/26/24 at 0952 stated “It had a lid, we haven’t been able to find it.” -3 IV poles in section labeled Isolation Supplies with white substance on the black plastic bases of all 3. 2 out of 3 IV poles with rusted metal poles. -Dialysis Machine #21 with peeling plastic directly below rinse bucket. -Patient chair at Dialysis Machine #11 with clean patient supplies on chair side table near dialysis machine. On same patient treatment chair opposite side tray table with staff face shield on the side tray table. -Staff medical glove cart with rusted metal pole and broken hand sanitizer holder. Broken hand sanitizer holder with bottle of hand sanitizer held in place with white tape. -Machine #10 Station #12 with blood splatter on outside of sharps container. -Machine #3 Station #9 with blood splatter on outside of sharps container. -Station #9 with blood splatter on outside of sharps container. -Approximately 6 inch reddish brown streak on floor next to patient wheelchair storage area near treatment area exit. -Station #14 wood section beneath chase box falling off. -Station #7 dialysis machine water tubing coated in white substance. -Machine #2 Station #19 with unlabeled syringe filled with clear fluid on chair side table. Staff #3 was at the clean Supply station. Staff #3 walked over to Surveyor at Machine #2 Station #19. Surveyor asked Staff #3 what was in the syringe. On 2/26/24 at 1103 Staff #3 stated “Heparin.” Surveyor asked if there was a label for it Staff #3 stated “Um, let me get it.” Staff #3 immediately walked over to the nurse’s station and Surveyor asked how long ago the medication was drawn up, Staff #3 stated “Um, about 10 minutes ago.” Surveyor asked if Staff #3 drew up the medication, Staff #3 stated “Yes, sir.” Staff #3 proceeded to walk 2 dialysis bays over to talk to the charge nurse. Surveyor walked over to Staff #3 and asked if the medication has been within eyesight since it was drawn, Staff #3 stated “Yeah.” -Patient medical station over counter cabinet with small paper cup labeled only Tylenol with 2 white circular pills inside. -All treatment area air vents over top of active patient treatments with large amount of dust. Surveyors asked the Facility Administrator during the Treatment Area observations if they were seeing what we’re seeing on 2/26/24 at 0928, and the Facility Administrator responded, “Absolutely, yeah” and confirmed the above observations. Observations on 2/26/24 at 0905, Registered Nurse Staff #7 touched machine #20 with gloved hands, walked over to clean supply cart, opened drawer and grabbed a blue absorbent pad, closed the drawer, walked to machine #2 set the blue absorbent pad down, touched the dialysis machine, walked back over to machine #20 and touched the dialysis machine. Both machines with active patient treatments. No glove changes or hand sanitization performed. Review of the facility’s monthly infection control (IC) audit tools for 1/3/24, 12/6/23, 11/2/23, 10/20/23 identified IC failures as documented: -gloves not changed per policy, -patients failed to perform hand hygiene when entering and exiting the treatment area, -Full PPE not worn by staff, visitors, transportation and physicians, -visible blood on surfaces, sharps, containers, chairs, wall, etc. -Murphy meter used and cleaned per P&P before and between each treatment. Review of the facility’s Policy and Procedure: Mixing Handling and Using 2% Citric Acid. Published 11/07/22, indicated in part;. 7. Swirl or swish the solution within the container so the solution comes into contact with all internal surface areas. Open and close spigot on mixing container to allow bleach to contact the fluid pathway. .”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 21863 Based on record review and interview, the facility failed to develop, implement, maintain, and evaluate an effective data-driven quality assessment and performance improvement program and to track, trend, and develop appropriate action and follow up as required to improve health outcomes and the prevention and reduction of medical errors and; in accordance with the facility’s policies. Specifically, the facility’s Quality Assessment and Performance Improvement Committee (QAPI) failed to: Ensure a thorough review of the patient mortalities monthly for 18 patient deaths (Patient’s #1-#18) identified from 1/1/23 to 2/26/24; to allow for identification, prevention and reduction of mortality and morbidities by developing an action plan to prevent and/or decrease mortality events. Findings included: Review of the facility’s QAPI Meeting minutes that are conducted monthly for July 2023 to January 2024 revealed they were not done. The last completed QAPI meeting minutes were from June 2023. Review of the facility’s Patient death and emergency transfer list for 1/1/23 to 2/27/24 revealed the following: - 18 deaths P#1 expired 11/11/23 P#2 expired 2/20/23 P#3 expired 1/8/24 P#4 expired 1/29/24 P#5 expired 6/10/23 P#6 expired 1/26/24 P#7 expired 11/15/23 P#8 expired 3/31/23 P#9 expired 9/28/23 P#10 expired 1/20/23 P#11 expired 4/26/23 P#12 expired 9/23/23 P#13 expired 8/12/23 P#14 expired 4/23/23 P#15 expired 3/25/23 P#16 expired 1/12/23 P#17 expired 6/21/23 P#18 expired 12/15/23 Interview on 2/27/24 at 13:40 PM in the facility conference room with S#2, surveyor reiterated the request for all TX HHSC [Texas Health and Human Services Commission] reports, S#1 stated “ I have not submitted any and I have not completed any mortality reviews. Review of the facility’s Policy and Procedure: Quality Assessment and Performance Improvement Program. Published 5/02/2022 indicated in part; The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven QAPI program with participation by the professional members of the interdisciplinary team (IDT). The program must reflect the complexity of the organization and services and must focus on indicators related to improved patient health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its QAPI program including continuous monitoring for the Centers for Medicare & Medicaid services (CMS) review.”

“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: 21863 Based on record review and interview, the dialysis facility failed to 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. Specifically, the facility staff failed to measure, analyze, track fluid management goals in order to implement corrective action(s) for the current 86 patients. As a result, the facility was not meeting fluid management goals of 35%. Findings included: Review of the facility’s QAPI Meeting minutes that are conducted monthly for July 2023 to January 2024 revealed they were not done. The last completed QAPI meeting minutes were from June 2023. Review of the Facility’s current census was 86 patients. Review of the facility’s crude mortality revealed there were 18 deaths in the past year from 1/1/23 to 2/26/24 which is an approximate 21 percent mortality rate. The facility is not completing mortality reviews to determine potential culpability or corrective action. The Dialysis Facility Report (DFR) for mortality rates threshold is at 10 percent. Review of the Hospitalizations from 1/1/23 to 2/26/24 revealed there were 12 hospital transfers in the past year without review to determine potential culpability or corrective action(s). The main diagnosis for hospitalizations was for “Fluid overload.” The facility’s charge nurse reported on 2/27/24 at 1:40 PM that their patients were not meeting target weight (fluid overload) which was at 54 percent. The facility’s charge nurse was not able to indicate the target weight goal for the facility when asked. On 2/27/24 at 3:00 PM, the Clinical Quality Manager indicated the facility’s target weight goal is 35% and the target weight was at 54 percent at the end of January, and as of today, the target weight was at 60 percent (increasing). Review of the facility’s dashboard reporting for 2/27/24 provided by the Clinical Quality Manager indicated the facility’s fluid management goals was at 54% at the end of January, today at 60% with 18 patients in AG-1, 8 patients in AG-2, and 25 patients in AG-3. Review of the patients in AG-2, “some patients needing EDW [estimated dry weight] change, several patients noted with post sitting b/p’s of 141-148. Planned inservice during the first week of March (2024).”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 21863 Based on treatment area observations, review of governing body minutes, review of Quality Assessment and Performance Improvements (QAPI) meeting minutes, Governing Board Meeting minutes, Infection Control Audit Tools and facility staff interviews with the governing body, it was determined the dialysis facility failed to ensure the governing body enforced rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients and to the general operation of the facility. Specifically, the governing body failed to: A.) ensure an adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients, See V757 for specific evidence B.) 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. CFR 494.30 CFC Infection Control not met. Refer to COP V110, V111 and V122 C.) ensure an effective QAPI program by developing, implementing, maintaining and evaluated an effective, data-driven, QAPI program, and that death mortality reviews were completed. CFR 494.110 CFC Quality Assessment & Performance Improvement not met. Refer to COP V625 and V626. D.) maintain a safe, functional, and comfortable treatment environment, CFR 494.60 CFC Physical Environment not met. Refer to COP V400 and V401 E.) ensure compliance with federal and state laws for reporting deaths and hospital transfers to Texas Department of Health and Human Services, CFR 494.20, CFC Compliance with Federal/State/Local Laws. Refer to COP V100 and V101. All 86 current facility patients are at risk to serious harm up to including death due to the dialysis facility failed to ensure the governing body enforced rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients and to the general operation of the facility. As a result, of the facility’s condition level non compliance with the following conditions cited: CFR 494.20 Compliance with Federal/State/Local Laws, CFR 494.30 Infection Control, CFR 494.60 Physical Environment, CFR 494.110 Quality Assessment & Performance Improvement, and CFR 494.180 Governance Review of the Governing Body Meeting minutes that are conducted quarterly revealed the last completed Meeting minutes were from January 23, 2023, and were incomplete. On 2/27/24, it was determined there was an Immediate Jeopardy risk to the patients health and safety. Policy and Procedure: Governing Body Policy. Published 7/03/2023. Policy reads in part: -Governing Body duties (generally in conjunction with the Medical Director) include but are not limited to: *Medical staff appointments, coverage, and compliance with facility policies *Facility professional staff appointments *Training and educating staff *Ensuring adequate staff coverage *Operation of Quality Assessment and Improvement Program *Directing and overseeing the facility ’ s internal grievance process and issues *Ensuring that facility emergency coverage and facility backup plans are in place and effective *Ensuring that requisite data is submitted timely and accurately to ESRD network and/or CMS, as required *Maintaining compliance and adherence to federal health care program requirements/state regulations including staffing Governing Body Secretary: The Clinical Manager generally serves as the Governing Body Secretary (or whomever the Governing Body otherwise designates). The Secretary is responsible for the following: -Recording, drafting, distributing, and maintaining the Minutes of each Governing Body meeting. -Developing and maintaining the requisite Governing Body Meeting Minutes Binder There are at least eight different reasons for convening a Governing Body meeting: the reasons and associated tasks to be accomplished are as follows: 3. Ad Hoc Governing Body Meeting: non-scheduled Governing Body meetings must be held in order for the Governing Body to meet its responsibility to address any issues, events, concerns etc. Such issues and concerns may be related, but not to be limited, to the following: -Physical environment issues (e.g., physical plant repairs, preventive maintenance issues) Governing Body Meeting Minute: Minutes for each Governing Body meeting must be maintained in each facility ’ s Governing Body Meeting Minutes Binder, or MMB. The binder must be maintained with complete, correct minutes, readily available at all times. The MMB contains confidential information and must be secured at all times.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 21863 Based on observation, staffing schedule review, and staff interview, the governing body failed to ensure an adequate number of qualified personnel were present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients. Specifically, the facility failed to provide adequate staffing to meet the patient needs when the Charge Nurse(CN)/Registered Nurse (RN) was observed providing direct patient care duties contrary to Rules and Regulations. Findings included: Observations on 2/26/24 at 09:00 AM there were multiple machine alarms not being addressed S#8 stated “You start hearing it in your dreams at night”. Station #19 the machine alarm started at 09:20 am the Charge Nurse (CN)/Registered Nurse (RN) #10 checked the alarm at 09:24. Station#17 the machine alarm started at 09:20, the surveyor had to direct the facility CN/RN #10 to check the alarm at 09:26. Review of P#28 Treatment Sheet dated 2/26/24 Prior to treatment Blood Pressure ( BP ) was 221/118 06:38 BP 186/111 AM S#7 documented bp elevated asymp, feet lowered, will try to lower bp with UF. 06:55 BP 178/108 S#3 documented Denies complaints patient alert. 07:15 BP 178/102 S#3 documented Denies complaints patient alert. 07:37 BP 170/111 S#3 documented Denies complaints patient alert. 07:42 BP 169/102 S#3 documented Denies complaints patient alert. 07:55 S#7 documented 2nd clonidine given pt asymp. Will continue to monitor. 08:01 BP 156/61 S#3 documented Denies complaints patient alert. 08:23 BP 152/101 S#10 documented PCT reports pt c/o feeling nauseated and hot BP stable Zofran given BS checked is at 42mg/dl will give oral gel glucose and snacks at chairside Will recheck sugar in 15 min. 08:47 BP 166/109 S#11 documented Pt states she is fine alert and oriented. 09:15 BP 168/115 S#10 documented Denies complaints, treatment discontinued without problem patient request AMA due to feeling hot: BS is now at 82 mg/dl, risks reviewed. Review of the facility reportable parameters for 2024 states in part. RN to MD reporting: 1. During dialysis B/P High BP systolic > 180 after 1 hour of tx and clonidine administered or diastolic >110 after 1 hour of tx 2. Post Dialysis B/P high BP systolic >180 diastolic > 100. During an interview with CN/RN, S#10 on 2/26/24, Surveyor asked if the MD had been notified of the high BP. S#10 stated “It seems like we have a lot of call ins, and today was one of them, that’s why I haven’t had time to call the MD as needed. I’ve been running all over the place today.” Review of the staff/patient daily assignments for 2/1/24 - 2/26/24 , documentation revealed the RN who was also the CN and the Medication Nurse was assigned all nursing responsibilities for all patients that included initiation and termination of patients that have a central venous catheter (CVC) and fistulas as well as administration of all patient ordered medications, assessments, and other CN duties. Review of patient/staff assignments identified 1 CN, 1 Medication Nurse and 4 PCTs (patient care technicians) assigned to provide direct patient care to the facility’s patient census of 86, on the following dates: February 7th, 8th, 15th and 26th. Direct patient care includes initiation, termination of all patients with a CVC, administration of medications and charge nurse duties. Documentation of patient treatments have the CN signatures for patient care. In an interview on 2/26/24 at 2:30 PM with the Director of Operations confirmed CN/RN (staff #10) does provide direct patient care. Review of the Governing Body Policy published 07/03/2023 version 1 indicated, in part under “ General Responsibilities” Governing Body duties ( generally in conjunction with the Medical Director) include but not limited to: Ensuring adequate staff coverage. Maintaining compliance and adherence to federal healthcare program requirements/state regulations including staffing. Regarding short staffing the Director of Operations stated on 2/26/24 at 1526 “I was not notified today. A majority of the time I have not been notified.””