Humble Dialysis, LP

“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: 30124 Based on interview and record review, the Facility’s Medical Director failed to report hospital transfers from the facility as required by the state regulations in one of ten records reviewed for patient ID #8). Texas Administrative Code (TAC) 117.48(a)(2) requires the facility to report hospital transfers of patients to the Texas Health and Human Services commission Facility Licensing Group as required within ten days of incident. Review of the Texas Health and Human Services instruction for completing ESRD Facility Incident Report Form from the Health and Human services Commission Facility Licensing Group requires the facility to report the following: Incident reports are required for the following: 2. Any ambulance transport from the dialysis facility to a hospital due to the patient’s emergent medical condition; this includes ambulance transports after a call to 911, whether or not the lights are flashing and or the siren is on as the ambulance leaves the facility or parking lot; do not report non-emergent transports. Record review of patient ID #8 medical record on 06/17/2025 along with the Facility Administrator. The following documentation was documented: 08/30/2024 patient hemodialysis treatment record documented hospital transfer of patient #8 for heart rate 177. Note from registered nurse documented, “Patient transported via EMS to emergency room at 08:43 AM.” Interview on the afternoon of 06/18/2025 with the Facility Administrator confirmed no record could be found where an incident report had been completed and sent to the state as required.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 30124 Based on observation and staff interview the facility’s direct patient care (PC) staff failed to ensure the vascular access was visible at all times during treatment on two out of ten patient observations. Ensuring proper visualization of the arteriovenous fistula access is important for the early recognition and prevention of bleeding from the patient’s access site. During a tour of the facility’s in-center treatment area on 06/17/2025 at 12:20 PM with Staff #B, the surveyor observed patients receiving dialysis treatment at the following stations with their access covered at stations 3 and 7. Patient ID #9 was observed at station #7 receiving hemodialysis with a blood flow rate 350 ml/min via a left upper arm fistula. Access was observed to be covered. Patient ID #13 was observed at station #3 receiving hemodialysis with a blood flow rate via right central venous catheter with a blood flow rate of 350 mil/minute. This was reported to Staff #B and above observations were confirmed. Staff #B discussed findings with each PC staff caring for the patients and the access was uncovered after findings noted.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 30124 Based on medical record review, policy review and staff interview the facility’s medical director failed to ensure staff follow their current policy and procedures in two of ten records reviewed (patient ID #s 6, 8). 1. Direct patient care (DPC) staff failed to report patient status changes during treatment that were out of acceptable parameters to the Registered Nurse (RN) to ensure a reassessment was performed and documented with appropriate interventions and/or physician notification, if required. 2. Adverse events were not completed by staff as required. Findings included: Policy and Procedures Reviewed: Review on the afternoon of 6/17/2025 along with the facility administrator, staff ID #B of the document titled “Patient Evaluations Reportable by Direct Patient Care staff to Charge Nurse”. Pre-Treatment : Weight - Gain or loss > 5 KG BP - Systolic > 175 or < 100 Diastolic > 110 Pulse - Pulse: >100 or < 60 Respirations - >28 or < 14 Intra-Dialytic BP - Systolic > 175 or < 100 Diastolic > 110 Post-Treatment Weight - Patient leaving 1 KG > or < of target weight BP - BP - Systolic > 160 or < 100 Diastolic > 110 Pulse - >100 or < 60 Any complaint voiced by patient to be reported. Policy and Procedure reviewed: Review of the facility’s current policy on 06/18/2025 titled “Adverse Event Reporting, reviewed 09/01/2011 reads.... all staff members and physicians who witness, discover or are involved in an event as defined in this policy are responsible for completing a adverse event report. An event can be defined as an occurrence that is anything other than expected for a dialysis treatment .... Review on 6/17/2025 of Patient ID #6 revealed the following: 05/30/2025 Direct patient care staff (DPC) documented the following. 07:01 pulse 58 07:31 pulse 58 10:01 pulse 57 There is no documentation acknowledging the heart rate was a reportable finding and was reported to the registered nurse by DPC staff. 06/09/2025 07:31 pulse 55 08:32 pulse 59 09:01 pulse 55 09:31 pulse 57 10:31 pulse 56 There is no documentation acknowledging the heart rate was a reportable finding and was reported to the registered nurse by PC staff. 06/16/2025 07:01 pulse 53 07:31 pulse 52 08:01 pulse 51 08:31 pulse 51 09:01 pulse 53 There is no documentation acknowledging the heart rate was a reportable finding and was reported to the registered nurse by PC staff. No documentation acknowledging the patient’s low heart rates was addressed from the registered nurse. Review on 6/17/2025 of Patient ID #8 revealed the following: Direct patient care staff (PC) documented the following. 06/04/2025 06:19 pulse 56 06:31 pulse 54 07:00 pulse 53 07:31 pulse 56 08:01 pulse 58 08:31 pulse 56 06/06/2025 06:28 pulse 55 06:31 pulse 51 07:01 pulse 54 07:31 pulse 55 09:31 pulse 53 06/09/2025 06:23 pulse 52 06:31 pulse 49 07:01 pulse 48 09:01 pulse 49 Note from PC staff “Heart rate trending low; Patient has no complaints”. 09:31 pulse 53 There is no documentation acknowledging the heart rate was a reportable finding and was reported to the registered nurse by PC staff. No documentation acknowledging the patient’s low heart rates was addressed from the registered nurse. Further review of patient ID #8 treatment record documented on 06/04 at 0619 AM by the PC staff an elevated venous pressure and clotting of the external blood lines and dialyze. The blood was not able to be returned to the patient resulting in blood loss and a new system had to be hung. There was no adverse event documentation found concerning this event. On the afternoon of 06/18/2025 an interview with the Facility Administrator confirmed the above findings and the facility’s reportable parameters and documentation required for out of parameter findings pre/intra/post dialysis treatment by the PC staff to the registered nurse. Facility Administrator also confirmed there was no documentation concerning the adverse event concerning patient #8 clotted of lines and dialyze as required.”

“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: 43999 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. The facility failed to ensure sufficient direct care staff be on site to meet the needs of the patients, and at least one licensed nurse was available on site for every twelve patients or portion thereof. During treatment of eight but not more than twelve patients, the registered nurse functioning as charge nurse shall not be assigned as direct care staff. Findings : During observation of the facility treatment room and review of patient/staff assignments on 5/5/25 & 5/6/25 it was found there were two registered nurses (RN) assigned to provide patient care with no designated CN (charge nurse) scheduled . Direct patient care includes patient care to all patients that have a CVC (Central venous catheter), medication administration, patient assessments, and supervision of patient care technician and other CN duties . Additional review of the facilities January 2025 through May 2025 staff schedule it was revealed the two RN (team leads )were scheduled with no designated CN scheduled. In an interview with staff # 4 and staff # 5 on 5/6/25 they confirmed the two RNs scheduled are assigned direct patient care and there is no designated CN available to charge once the eighth patient is started on treatment.”

“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: 43999 Based on observation and interview, the facility failed to provide a safe and sanitary environment to minimize the transmission of infectious agents. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility. Findings: Based on observation and staff interview the facility failed to follow standard infection control practices. Findings were: Observations on the morning of 6/15/21 revealed a charge nurse carrying medications in medication cups to the different patient stations. The clipboard was placed on the dialysis machine, medications were given, and the clipboard was returned to the common clean area. The clipboard was not disinfected between patients. 2 out of 4 staff members removed paper dialysis prescription from the dialysis machine and placed in a clean area. The above findings were confirmed in an interview with staff #2. During a tour of the facility on 07/18/2016 at 8:48 AM the following infection control issues and safety issues were observed: Based on observation, interview, and facility policy review, the facility failed to ensure that one of two phoenix meters were cleaned and disinfected prior to returning to the storage area for the next use. This deficient practice had the potential to result in increased infections to all 94 incenter patients receiving incenter care at this hemodialysis unit. Findings include: During an observation on the treatment floor on 11/18/24 at 11:20 AM. Patient Care Technician (PCT)13 was observed using the phoenix meter to test the conductivity of a machine at station 10. PCT13 then returned the phoenix meter to the storage area for the next use without disinfecting the meter. During an interview with PCT13 on 11/18/24 at 12:30 PM, he/she confirmed that he/she failed to disinfect the meter prior to returning it to the storage area. During an interview with the Administrator on 11/18/24 at 1:30 PM he/she confirmed that staff are supposed to disinfect the phoenix meter after use. Review of facility policy titled, “Measuring Conductivity, Temperature Using the Phoenix Meter” dated 4/22 states, “The outside of the phoenix meter must be disinfected after use prior to returning the meter to the storage area.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 43999 Based on observation and staff interview the facility failed to maintain and ensure the safety of the patients, the staff and the public. Findings: During a tour of the facility on 5/6/25, the following was observed: -corners had cracked or missing laminate exposing particle board. -The door leading to the biohazard waste area from the treatment area would not close. -The Biohazard room door was propped open. - The medication refrigerator in a room off the treatment room was plugged into an extension cord and ran through the door. -There was an extension cord placed from an electrical outlet on the lab area countertop that was used to charge the facility IV machines. - In the Home training room an extension cord was plugged in to the wall outlet and ran up and behind the clean sink to a computer on the counter. -The loading dock accessed from the water and supply room had damage around the door and a large opening at the bottom of the door.-The door was difficult to open and close as it appeared the door was damaged. Two large pallets with facility supplies were in the entry way at the loading dock area. -In the conference room, an extension cord was placed from an adjourning room to provide additional power for equipment. During the facility tour and observation on 5/7/25 with the Facility Administrator the findings above were acknowledged to be unsafe and in need of repair. There was no documentation provided during the survey that reflected pending repair or immediate actions to correct safety concerns.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 43999 The facility failed to include evidence of the patient or the patient’s designee input. The plan of care documents reviewed did not have patient’s signatures or reason the signature were not provided. Findings: Review of 5 of 5 patient’s annual plan of care (POC) did not provide documentation the patient (or patient’s legal representative) participated or provided input when the POC completed by the interdisciplinary team. There was no signature on the POC that the information was reviewed with the patient (or patient’s legal representative) for 5 of 5 patients reviewed. During an interview on the afternoon of 5/6/25, the Facility Administrator, staff #4 confirmed the physician signs patient care plans but does not meet with the interdisciplinary team to discuss patient’s POC; patients have not been invited to care plan meetings; the POC’s are not reviewed with the patients after completion by the interdisciplinary team. The Facility Administrator confirmed there were no patient signatures indicating the POC had been reviewed with the patients, and there were no progress notes documenting that the POC had been reviewed with the patient or patient representative.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 31974 Based on interview and review of documentation, the facility failed to take actions that result in performance improvement, and track performance to ensure that improvements are sustained over time. Findings: Review on 5/8/25 of the facility QAPI (Quality Assurance and Performance Improvement) meeting notes dated 4/16/25 for the reporting month of March 2025 did not reflect actions plans, monitoring or followup to improve patient vaccination status. During an interview on the afternoon of 5/6/25, Staff #4, the Facility Administrator and Staff #5, the Clinical Coordinator, verified that the existing QAPI program was not updating action plans to reflect the facility is tracking performance in patient vaccination status to ensure that improvements are made in the facility vaccination system and sustained over time”

“Plan Based on All Hazards Risk Assessment CFR(s): §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: 10802 Based on record review and interview, the facility’s governing body failed to evaluate the facility’s vulnerability to disaster and develop a plan to address identified risks. Based on record review and interview , the facility failed to conduct tabletop drill with facility’s staff based on facility’s hazard risk vulnerability identified. Findings: Review of the facility’s emergency plan revealed the following documentation: “ A hazard vulnerability analysis (HVA) is typically the first step in disaster planning for an organization.” Review on 05/22/2024 of the facility’s emergency plan revealed no documentation that the facility’s governing body conducted an evaluation of it’s vulnerability to disaster ( natural and manmade) and develop a plan to address each area of vulnerability. During a review of the facility’s emergency plan and interview with the Facility’s Administrator on 05/22/2024, the Surveyor reviewed the facility’s emergency plan with the Facility’s Administrator. Interview revealed she said a vulnerability analysis was not done to identify hazard risk in the facility. Review of the facility’s emergency plan dated 3/14/2022, revealed no documentation that the facility’s governing body conducted an evaluation of its vulnerability to disaster ( natural and manmade) and develop a plan to address each area of vulnerability. Review of the record revealed no documentation that the facility conducted a tabletop drill with its facility’s staff to address the vulnerability to disaster ( natural and manmade). During an interview on 05/22/2024 with the Facility’s Administrator revealed she said she had not conducted a tabletop drill.”

“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: 10802 Based on observation, interview and record review facility’s direct care staff failed to clean and disinfect Hansen connectors, blood pressure cuffs, back of hemodialysis machines water hoses, television console and chase, water boxes during terminal cleaning of the unit in 4 of 7 staff observed terminally hemodialysis stations Licensed Vocational Nurse (I), Registered Nurse (M), Patient Care Technician (C) and (D) Findings: Review of the facility’s current policy and procedure on Cleaning Treatment Stations and Machines Between Patients; Policy #703 directs staff as follows: Policy” After each treatment the dialysis chair, machine, and any areas visibly soiled will be cleaned and wiped down with disinfectant. All direct patient care staff will be trained to accomplish this task according to procedure.” Procedure “ Correct cleaning and disinfection with cloth soaked with bleach 1:100 or other “intermediate level disinfectant” (a disinfectant that kills bacteria and most viruses and accomplished by using a tuberculocidal “hospital disinfectant) of environmental surfaces, including patient chair surfaces, while chair is in Trendelenburg position, dialysis equipment surfaces, blood pressure cuff, call bells/remote control, adjacent tables dialysate lines oxygen tanks, or machines and IV poles. If used the outside surfaces of the dialysate must be wiped with disinfectant between patient uses to prevent transmission of dangerous pathogens. Thoroughly wipe down all exterior surfaces on the machine. Discard any contaminated supplies, barriers etc. into the biohazard waste and clean the area.” Licensed Vocation Nurse (I), Hemodialysis Station # 1, Hemodialysis Machine #16 On 05/20/2024 at 10:10 a.m. Licensed Vocational Nurse ( I) was observed at hemodialysis station #1, hemodialysis machine # 16. Licensed Vocational Nurse (I) was terminally cleaning the hemodialysis station post hemodialysis of a patient. Observation revealed during terminal cleaning of the station, Licensed Vocational Nurse ( I) did not clean/ disinfect the Hansen connectors, sides and back of the hemodialysis machine, television console, chase, hoses and water box. The Licensed Vocation Nurse wiped over the Hansen connectors encased in the metal covering. Licensed Vocation Nurse (I), Hemodialysis Station #14, Hemodialysis Machine #27 On 05/20/2024 at 10:20 a.m. Licensed Vocational Nurse (I) was observed at hemodialysis station #14, hemodialysis machine # 27. Licensed Vocational Nurse (I) was terminally cleaning the hemodialysis station post hemodialysis of a patient. Observation revealed during terminal cleaning of the station, Licensed Vocational Nurse ( I) did not clean/ disinfect the Hansen connectors, sides and back of the hemodialysis machine, television console, chase, hoses and water box. The Licensed Vocation Nurse wiped over the Hansen connectors encased in the metal covering. Licensed Vocation Nurse (I) Hemodialysis station # 2, Hemodialysis machine #28 On 05/20/2024 at 10:40 a.m. Licensed Vocational Nurse ( I) was observed at hemodialysis station #2, hemodialysis machine #28. Licensed Vocational Nurse (I) was terminally cleaning the hemodialysis station post hemodialysis of a patient. Observation revealed during terminal cleaning of the station Licensed Vocational Nurse ( I) did not clean/ disinfect , sides and back of the hemodialysis machine, television console , chase, and water box. Licensed Vocation Nurse (I ) Hemodialysis station # 13, Hemodialysis Machine #7 On 05/20/2024 at 11:00 a.m. Licensed Vocational Nurse ( I) was observed at hemodialysis station #13, hemodialysis machine # 7. Licensed Vocational Nurse (I) was terminally cleaning the hemodialysis station post hemodialysis of a patient. Observation revealed during terminal cleaning of the station Licensed Vocational Nurse ( I) did not clean/ disinfect, sides and back of the hemodialysis machine, television console, chase, and water box. On 05/20/2023 at 11:10 a.m. Registered Nurse (M) asked Licensed Vocational Nurse (I) if the station was clean and ready to be set up. Licensed Vocational Nurse (I) responded “yes”. Registered Nurse (M) then was observed priming clean blood lines and dialyzer in preparation for an oncoming patient. The Surveyor notified her that stations 1, 2 , 13 and 14 Hansen connectors , back of hemodialysis machines, water hoses, television console, chase, water boxes were not cleaned and disinfected during terminal cleaning of the units. The Surveyor notified License Vocational Nurse (I) that she did not clean and disinfect stations 1, 2 , 13 and 14 Hansen connectors, back of hemodialysis machines, water hoses, television console, chase, water boxes during terminal cleaning of the units. Licensed Vocational Nurse states “ I am sorry.” 48020 Patient Care Technician (C) Station #24 - hemodialysis machine #34 Observation on 05/20/2024 at 10:45 a.m. revealed Patient Care Technician (C) terminally cleaning station #24 post hemodialysis treatment of a patient. During terminal cleaning of the hemodialysis machine #34 at station #24, Patient Care Technician (C) failed to clean and disinfect both sides of the blood pressure cuff, hand sanitizer and holder attached to the hemodialysis machine, dialysate lines, wall box and chase cabinet. Station #23 - hemodialysis machine #18 Subsequent observation on 05/20/2024 at 10:50 a.m. revealed Patient Care Technician (C) terminally cleaning station #23 post hemodialysis treatment of a patient. During terminal cleaning of the hemodialysis machine #18 at station #23, Patient Care Technician (C) failed to clean and disinfect the stethoscope, both sides of the blood pressure cuff, hand sanitizer and holder attached to the hemodialysis machine, dialysate lines, wall box and chase cabinet. The Surveyor notified Patient Care Technician (C) at 10:57 a.m. that she failed to clean and disinfect the stethoscope, both sides of the blood pressure cuff, hand sanitizer and holder attached to the hemodialysis machine, dialysate lines, wall box and chase cabinet at stations #23 and #24. Patient Care Technician (C) said, “I did not clean the lines all the way back to the chase.” Patient Care Technician (D) Station #20 - hemodialysis machine #19 Observation on 05/20/2024 at 11:03 a.m. revealed Patient Care Technician (D) terminally cleaning station #24 post hemodialysis treatment of a patient. During terminal cleaning of the hemodialysis machine #19 at station #20, Patient Care Technician (D) failed to clean and disinfect the blood pressure cuff sitting in the holder (not used by the previous patient), hand sanitizer and holder attached to the hemodialysis machine, Hansen connectors, back of the machine, dialysate lines, wall box and chase cabinet. The Surveyor notified Patient Care Technician (C) at 11:17 a.m. that he failed to clean and disinfect the blood pressure cuff sitting in the holder, hand sanitizer and holder attached to the hemodialysis machine, Hansen connectors, back of the machine, dialysate lines, wall box and chase cabinet. at stations #20. Patient Care Technician (D) said, “I was rushing.””

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s nurses failed to implement infection control measures by not using aseptic technique in dressing changes and disconnection of a central venous catheters in 2 of 8 sampled nurses: Registered Nurse (C) Patient #6 and Registered Nurse (E) Random Patient #14 Findings: Review of the facility’s current policy and procedure on In-Center Hemodialysis Catheter Care; Policy #05.101 directs staff as follows: II. POLICY: It is the policy in place to minimize the risk of infection and trauma to the patient and hemodialysis catheter, to observe for signs of infection and facilitate prompt treatment. IV. PROCEDURE: D. Clean the exit site: 1. Use aseptic technique. To clean exit site: apply ExSept solution in circular motion working from catheter exit site outwards for at least 30 seconds. Cover an area of 10 cm in diameter. Perform this step twice. Do not blot excess solution from skin. 2. Allow the area to dry completely. 3. Remove gloves and discard, perform hand hygiene and re-glove. 4. Apply sterile 2x2 with Hypafix tape or sterile Island Dressing 5. Document the procedure and observation. Registered Nurse (B) Patient #6 On 05/20/2024 at 7:20 a.m., Patient #6 was observed at station #17 receiving central venous catheter (CVC) care before the hemodialysis treatment. Registered Nurse (B) was observed to clean the CVC exit site with gauze soaked in antiseptic solution and then she applied the sterile Island Dressing without first, removing her gloves and performing hand hygiene as directed by the policy and procedure. During the CVC dressing change process, the patient’s face mask was not covering his nose. The Surveyor notified Registered Nurse (B) at 12:15 p.m. after shift changeover of the break in infection control by: 1- allowing the patient’s nose to be uncovered during the CVC dressing change. Registered Nurse (B) stated, “I didn’t notice it until after I was done.” 2- failing to remove her gloves and perform hand hygiene before she applied the sterile Island Dressing. Registered Nurse (B) stated, “Yes, I should have removed my gloves and washed my hands.” Registered Nurse (E) Random Patient #14 On 05/20/2024 at 10:26 a.m., Registered Nurse (B) was observed at station #30 disconnecting central venous catheter (CVC) from the hemodialysis machine of Random Patient #14. Registered Nurse (B) flushed the CVC lumens, applied the endcaps and wrapped the CVC with gauze. The patient did not have his facemask covering his nose during the process. The Surveyor notified Registered Nurse (E) at 10:34 a.m. of the break in infection control by allowing the patient’s nose to be uncovered while she disconnected the patient’s CVC from the hemodialysis machine. Registered Nurse (E) stated, “Yes, I noticed it too late.””

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 10802 Based on observation, interview and record review the facility failed to ensure patients receive hemodialysis treatment based on physician’s orders in 5 of 12 sampled patients. Patient #8, 9, 5, 12 and 11 Findings: Review of the facility’s current Policy and Procedure on Initiating Dialysis Treatment via Peripheral Vascular Access, Policy #906 directs staff as follows: Policy: 2. Prior to the initiation of treatment the physicians’ orders will be checked to verify correct dialyzer, correct dialysate bath, correct settings and length of treatment and other orders specific to the dialysis treatment of the particular patient. Patient #8 On 05/21/2024 at 7:09 a.m. Patient #8 was observed on the treatment unit of the facility at station number 9 . The patient was utilizing hemodialysis machine #26. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 700 mls/ minute. Review of the patient’s medical record revealed a physician’s order dated 4/16/2024 for dialysate flow rate of 800 mls/ minute. Interview during the observation with Patient Care Technician ( C) who is assigned to the patient revealed she states “ The TMP keeps going up. Once it is decreased to 700 the alarm goes off.” Review of the patient’s clinical record ( treatment sheet) dated 04/18/2024 revealed the patient’s hemodialysis treatment was initiated at 6:25 a.m. at a dialysate flow rate of 700 mls/ minute. 6:25 a.m. - 09:31 the patient’s dialysate flow rate was decreased to 700 mls/ minute. There was no documented justification why the patient’s dialysate flow rate was not maintained at the prescribed rate of 800 mls/ minute. The record revealed the patient utilized hemodialysis machine #26 for hemodialysis treatment. Patient #9 On 05/21/2024 at 7:37 a.m. Patient #9 was observed on the treatment unit of the facility at station number 13 . The patient was utilizing hemodialysis machine #7. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 700 mls/ minute. Review of the patient’s medical record revealed a physician’s order dated 2/23/2024 for dialysate flow rate of 800 mls/ minute. Interview with Registered Nurse - assigned to the patient revealed she said the machine dialysate flow rate cannot reach 800 mls/ minute due to high transmembrane pressure and so she decreased it with a one time order from the physician. Review of the patient’s clinical record located in the computer revealed a physician’s order dated 03/23/2024 for dialysate flow rate of 800 mls/ minute. Treatment sheet dated 04/25/2024: Review of the patient’s clinical record ( treatment sheet) dated 04/25/2024 revealed the patient’s hemodialysis treatment was initiated at 6:33 a.m. at a dialysate flow rate of 800 mls/ minute. 7:04 a.m. - 10:38 the patient’s dialysate flow rate was decreased to 700 mls/ minute. There was no documented justification why the patient’s dialysate flow rate was not maintained at the prescribed rate of 800 mls/ minute. The record revealed the patient utilized hemodialysis machine #26 for hemodialysis treatment. Treatment sheet dated 04/30/2024. Review of the patient’s clinical record ( treatment sheet) dated 04/30/2024 revealed the patient’s hemodialysis treatment was initiated at 6:40 a.m. at a dialysate flow rate of 800 mls/ minute. 7:02 a.m. - 10;47 a.m. the patient’s dialysate flow rate was decreased to 700 mls/ minute. There was no documented justification why the patient’s dialysate flow rate was not maintained at the prescribed rate of 800 mls/ minute. Review of the patient’s treatment sheet and interview with Registered Nurse ( R) on 05/21/2024 at 11:38 a.m. revealed she states, “ I must have overlooked it .” Interview on 05/21/2024 (11:40 a.m.) with Registered Nurse (Q) revealed she states, “ probably the TMP started going up so it was decreased.” The record revealed the patient utilized hemodialysis machine #22 for hemodialysis treatment. Interview on 05/21/2024 with the facility’s Chief Biomedical Technician revealed he said the hemodialysis machine #s 22, 26 and 7 had preventative maintenance and he was not aware that the dialysate flow rate would not go up to 800 mls/ minute based on high TMP. 48020 Patient #5 On 05/20/2024 at 7:46 a.m., Patient #5 was seated at station #28 machine #28 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 700 mL/min via left femoral vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record revealed a physician’s order dated 05/10/2024 for Potassium 2.0 mEq/L dialysate setting. Observation with Patient Care Technician (A) at 8:07 a.m. revealed the dialysate settings on the patient’s hemodialysis machine were: potassium 3 mEq/L, calcium 2.5 mEq/L, bicarbonate 32 mEq/L, and sodium 137 mEq/L. When the Surveyor pointed out the discrepancy in dialysate settings, Patient Care Technician (A) said “I should have checked it.” Patient #12 On 05/21/2024 at 7:33 a.m., Patient #12 was seated at station #25 machine #22 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 700 mL/min via left femoral vascular access. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record revealed a physician’s order dated 05/02/2024 for dialysate flow rate of 800 mL/min. Interview with Registered Nurse (H) revealed there are two machines that they were not able to run the prescribed dialysate of 800 mL/min due to a High Flow Error alarm. Treatment sheet dated 05/14/2024 Review of the patient’s treatment sheet dated 05/14/2024 revealed the patient received hemodialysis treatment on machine #11. Documentation indicated the patient was prescribed a dialysate flow rate of 800 mL/min but received hemodialysis treatment at a dialysate flow rate of 700 mL/min from 7:13 a.m. - 10:20 a.m. There was no justification documented for the dialysate flow rate of 700 mL/min. Patient #11 On 05/21/2024 at 8:15 a.m., Patient #11 was seated at station #27 machine #6 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min via left femoral vascular access. The patient was utilizing an Optiflux 250 non reuse dialyzer. Review of the patient’s clinical record revealed a physician’s order dated 05/13/2024 for dialysate flow rate of 800 mL/min. Review of the patient’s treatment sheet dated 05/16/2024 revealed the patient received hemodialysis treatment on machine #16. Documentation indicated the patient was prescribed a dialysate flow rate of 800 mL/min but received hemodialysis treatment at a dialysate flow rate of 600 mL/min from 6:34 a.m. - 10:30 a.m. There was no justification documented for the dialysate flow rate of 600 mL/min. Treatment sheet dated 05/14/2024 Review of the patient’s treatment sheet dated 05/14/2024 revealed documentation which indicated the patient was prescribed a blood flow rate of 400 mL/min but received hemodialysis treatment at a blood flow rate of 330 mL/min from 06:22 a.m. - 10:34 a.m. There was no justification documented for the blood flow rate of 330 mL/min. Treatment sheet dated 05/11/2024 Review of the patient’s treatment sheet dated 05/11/2024 revealed documentation which indicated the patient was prescribed a blood flow rate of 400 mL/min but received hemodialysis treatment at a blood flow rate of 350 mL/min from 06:35 a.m. - 10:35 a.m. There was no justification documented for the blood flow rate of 350 mL/min. Interview with Registered Nurse (H) at 11:35 a.m. revealed he forgot to document that Patient #11 did not receive hemodialysis treatment at the prescribed blood flow rate because of his new central venous catheter.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 48020 Based on record, review and interview the Facility’s Medical Director failed to ensure patients’ attending nephrologist conduct and document monthly visits on patients in 1 of 13 sampled patients: Patient #4. Patient #4 On 05/20/2024 at 7:10 a.m., Patient #4 was seated at station #19 machine #11 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and a dialysate flow rate of 800 mL/min via left upper arm vascular access. The patient was utilizing an Optiflux 200 non reuse dialyzer. Review of the patient’s clinical record (physician’s progress notes) revealed physician progress note dated 02/07/2024, 03/27/2024 and 05/08/2024. There was no documented physician progress note for April 2024. There was no documented physician progress note every month as required by federal regulations”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 10802 Based on observation, interview, and record review, the Facility’s Medical Director failed to ensure all staff complete annual skills competency in 3 of 6 staff personnel file reviewed: Chief Biomedical Technician (J), Patient Care Technician (A) and Registered Nurse (B) Findings: On 05/20/2024 and 05/2022 Facility’s Chief Biomedical Technician (J) was observed in the facility. Review on 05/22/2024 of the Facility Chief Biomedical Technician (J’s) personnel and training file revealed a skilled competency evaluation dated 1/26/2023 which was conducted at a facility not affiliated with this facility. On 05/22/2024 at 9:30 a.m., the Surveyor reviewed the personnel and training file with Facility’s Chief Biomedical Technician (J). He confirmed that he was not current on his skilled competency evaluation. 48020 Patient Care Technician (A) On 05/20/2024 Patient Care Technician (A) was observed on the treatment floor of the facility providing care and services to hemodialysis patients. Review of Patient Care Technician (A’s) personnel and training file revealed she was hired to the facility on 02/01/2020. Review of Patient Care Technician (A’s) personnel and training file revealed the most current water skills competency signed by the employee, Clinical Manager and Medical Director on 01/27/2023. Review of the facility’s staff schedule revealed Patient Care Technician (A) was scheduled for water room duties on: 05/15/2024 and 05/18/2024. Registered Nurse (B) On 05/20/2024 Registered Nurse (B) was observed on the treatment floor of the facility providing care and services to hemodialysis patients. Review of Registered Nurse (B’s) personnel and training file revealed she was hired to the facility on 12/01/2013. Review of Registered Nurse (B’s) personnel and training file revealed the most current competency exam was completed on 04/14/2023 and the water skills competency signed by the employee, Clinical Manager and Medical Director on 01/27/2023. Review of the facility’s patient schedule revealed Registered Nurse (B) provided care and services to patients on: 05/08/2024, 05/10/2024, 05/13/2024, 05/15/2024, 05/17/2024 and 05/20/2024. Interview on 05/22/2024 at 10:15 a.m. with Facility Administrator (P) revealed she said, “These are missing, and I need to get them updated.””