Davita Central Houston Dialysis

“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: 48020 Based on observation and interview, the facility’s staff assigned duties in the Water Room failed to verify that the acid storage tank is clean. Findings: Water Room Observation on 01/15/2025 at 8:20 a.m. of the water room revealed Patient Care Technician Preceptor (I) wiping the outside of the left acid storage tank with a white cloth. The outside of the acid storage tank had brown streaks on side of the tank that contains the hose. The brown streaks were observed starting from the top to the bottom of the tank. During the observation, the Surveyor interviewed Patient Care Technician Preceptor (I) who said that she was wiping the tank with “RO (reverse osmosis) water” which is dialysis quality water. Subsequent observation of the acid storage tank at 12:30 p.m. revealed the brown streaks were no longer present. Interview with Facility Administrator (H) at 12:40 p.m. confirmed that the staff should be cleaning the outside of the acid storage tanks.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to: perform hand hygiene after removal of contaminated gloves per the facility’s policy in 1 of 3 staff observed: Patient Care Technician (D), B) encourage patients to perform hand hygiene after treatment per the facility’s policy in 1 of 3 staff observed: Patient Care Technician (D) and Patient #9. C) change gloves when going from a “dirty” area or task to a “clean” area or task per the facility’s policy in 1 of 3 staff observed: Patient Care Technician (F) Findings: Review of the facility’s current policy and procedure: Infection Control for Dialysis Facilities, Policy 1-05-01, directs the staff as follows: HAND HYGIENE 1. All teammate, Physicians and Non-Physician (NPP) will perform hand hygiene a. Upon entering and exiting the patient treatment area, b. Prior to gloving and immediately after removal of gloves 2. Patients and caregivers will be encouraged to a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area. PPE 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station, this will include patients and visitors assisting with procedures such as self-cannulation or holding access sites. a. Gloves should be changed when: i. When soiled with blood, dialysate or other body fluids ii. When going from a “dirty” area or task to a “clean” area or task ... Patient Care Technician (D) Observation on 01/15/2025 at 7:10 a.m., revealed Patient Care Technician (D) was cannulating the vascular access of a Patient #5 at station #13 before the hemodialysis treatment began. Patient Care Technician (D) used a knuckle on his right hand to silence the alarm on the hemodialysis machine. He then removed his contaminated gloves, grabbed clean gloves from the box on the computer cart and donned the clean gloves without washing/sanitizing his hands. Subsequent observation at 10:55 a.m. revealed Patient Care Technician (D) getting gauze from the nurse’s station drawer. With the gauze in his hands, he donned gloves, walked over to station #11, silenced the alarm on the hemodialysis machine and removed the gloves. Patient Care Technician (D) then grabbed new gloves from the box on the computer cart, walked over to Station #13, laid the gauze on the clean supply field, donned the new pair of gloves, opened and applied the gauze to the vascular access of Patient #5 at station #13 after removing one of his vascular access needles. Interview with Patient Care Technician (D) at 11:30 a.m.: the Surveyor notified Patient Care Technician (D) that he failed to wash/sanitize his hands after removing his contaminated gloves and before donning clean gloves. Patient Care Technician (D) said, “Okay.” Patient Care Technician (D) Patient #9 Observation on 01/15/2025 at 9:11 a.m., revealed Patient #9 holding his vascular access with a gloved hand at station #11. After the bleeding ceased, Patient Care Technician (D) taped the patient’s vascular access site. The patient donned a pair of his personal gloves and used his Rollator to walk over to the weigh scale to be weighed. After being weighed by Patient Care Technician (D), Patient #9 left the treatment floor without washing/ sanitizing his hands. The Surveyor immediately notified Patient Care Technician (D) that he did not encourage the patient to wash/sanitize his hands after holding his vascular access site. Patient Care Technician (D) said, “He speaks Spanish and “I usually get ___ (staff member) to translate for me but I didn’t get him today.” Patient Care Technician (F) Observation on 01/15/2025 at 7:10 a.m., revealed Patient Care Technician (F) preparing to cannulate the vascular access of a patient at Station #1. With his gloves on his hands, he removed his googles from the top of his head and placed them over his eyes. With the same gloves, he picked up the roll of tape from the clean supply field, tore strips of tape and applied them to the patient’s vascular access without removing his gloves and performing hand hygiene. Interview with Patient Care Technician (F) at 10:02 a.m.: the Surveyor notified Patient Care Technician (F) that he failed to remove his contaminated gloves, wash/sanitize his hands, and don clean gloves before applying the tape to the patient’s vascular access. Patient Care Technician (F) said, “Okay.””

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 48020 Based on observation and interview, facility’s direct care staff failed to implement the facility’s policy and procedure by placing clean supplies adjacent to a sink without a splash guard in place in 2 of 4 sinks observed in the hemodialysis treatment area. Findings: Review of the facility’s current policy and procedure: Infection Control for Dialysis Facilities, Policy 1-05-01, directs the staff as follows: “FACILITY HYGIENE 1. Sinks should be easily accessible and readily available in the treatment area and in other appropriate areas such as the medication area, home training room, and isolation area/room a. Sinks must be plumbed with both hot and cold water. b. Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place ....” Observation on 01/15/2025 at 7:49 a.m. of the hemodialysis treatment area revealed the following: Nursing Station #1 (nearest to the lobby): Observation of Nursing Station #1 revealed a clean sink with clean supplies placed on the counter of the sink with no splash guard in between them. The supplies consisted of : 6- treatment initiation packs on the left side of the sink 1- treatment initiation pack on the right side of the sink The packs consisted of supplies used to either cannulate an arteriovenous fistula or graft or initiate treatment on a central venous catheter. The packs were wrapped in a blue absorbent pad clamped by a blue hemostat. Nursing Station #2 (nearest to the laboratory): Observation of Nursing Station #2 revealed a clean sink with clean supplies placed on the counter of the sink with no splash guard in between them. The supplies consisted of : 2- cardboard boxes of 2x2 gauze 2- empty 2x2 gauze cardboard boxes that had highlighters, a thermometer, a couple of unused masks 1- empty 2x2 gauze cardboard box with 3 pre-filled saline syringes with a roll of tape on each one of them The two cardboard boxes with the 2x2 gauze was wet on the side nearest to the sink. Surveyor notified Facility Administrator on 01/15/2025 at 12:40 p.m. of the break in infection control by storing clean supplies on the clean sink counter where the supplies can become contaminated by hand washing activities. The Facility Administrator said, “They should be using the drawers on the nurse’s stations.””

“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: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 5 of 12 sampled and closed patients: Patient #s 2, 4, 5, 6, 10 Findings: Review of the facility’s current policy and procedure on Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, Policy 1-03-08, directs staff as follows: “POLICY 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting)” Patient #2 On 01/15/2025 at 7:32 a.m. Patient #2 was observed on the treatment floor of the facility at station #1 machine #19. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a left upper arm vascular access. Treatment sheet review: Treatment Time Review of the patient’s treatment sheet dated 01/08/2025 revealed the Dialysis Prescription Treatment Time of 3h 30m (210 min). The Post-Treatment Vitals documentation indicated the Treatment Duration was 198 min (3h 18m) instead of the prescribed 3h 30m (210 min). There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Patient #4 On 01/15/2025 at 7:35 a.m. Patient #4 was observed on the treatment floor of the facility at station #18 machine #2. The patient was receiving hemodialysis treatment at a blood flow rate of 300 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a left central venous catheter. Treatment sheet review: Treatment Time Review of the patient’s treatment sheet dated 01/13/2025 revealed the Dialysis Prescription Treatment Time of 3h 30m (210 min). The Post-Treatment Vitals documentation indicated the Treatment Duration was 148 min (2h 28m) instead of the prescribed 3h 30m (210 min). There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Review of the patient’s treatment sheet dated 01/08/2025 revealed the Dialysis Prescription Treatment Time of 3h 30m (210 min). The Post-Treatment Vitals documentation indicated the Treatment Duration was 167 min (2h 47m) instead of the prescribed 3h 30m (210 min). There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Blood Flow Rate Review of the patient’s treatment sheet dated 01/10/2025 revealed the Dialysis Prescription Blood Flow Rate of 350 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 250 mL/min from 7:11 a.m. - 9:32 a.m. There was no justification documented for the blood flow rates of 250 mL/min. Patient #5 On 01/15/2025 at 7:41 a.m. Patient #5 was observed on the treatment floor of the facility at station #13 machine #14. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a left upper arm vascular access. Treatment sheet review: Treatment Time Review of the patient’s treatment sheet dated 01/15/2025 revealed the Dialysis Prescription Treatment Time of 3h 45m (225 min). The Post-Treatment Vitals documentation indicated the Treatment Duration was 212 min (3h 32m) instead of the prescribed 3h 45m (225 min). There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Blood Flow Rate Review of the patient’s treatment sheet dated 01/06/2025 revealed the Dialysis Prescription Blood Flow Rate of 400 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 200 mL/min from 7:22 a.m. - 9:01 a.m. There was no justification documented for the blood flow rates of 200 mL/min. Patient #6 On 01/15/2025 at 7:53 a.m. Patient #6 was observed on the treatment floor of the facility at station #9 machine #3. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a left upper arm vascular access. Treatment sheet review: Treatment Time Review of the patient’s treatment sheet dated 01/03/2025 revealed the Dialysis Prescription Treatment Time of 3h 30m (210 min). The Post-Treatment Vitals documentation indicated the Treatment Duration was 201 min (3h 21m) instead of the prescribed 3h 30m (210 min). There was no documented justification why the patient did not receive the hemodialysis treatment at the prescribed time nor whether the patient signed an early termination Against Medical Advice form. Patient #10 Review of the patient’s clinical record on 01/16/2025 revealed the patient was admitted to facility on 03/08/2011. The patient had diagnoses of end-stage renal disease, cerebrovascular accident, hypertension, hyperlipidemia, type 2 diabetes mellitus, vascular stent, pulmonary vascular congestion, on three times a week hemodialysis. Treatment sheet review: Dialysate Flow Rate Review of the patient’s treatment sheet dated 01/13/2025 revealed the Dialysis Prescription Dialysate Flow Rate of 500 mL/min but the patient received the hemodialysis treatment at a dialysate flow rate of 800 mL/min from 7:02 a.m. - 10:02 a.m. There was no justification documented for the dialysate flow rate of 800 mL/min. Interview during record review on 01/16/2025 at 12:35 p.m. with Facility Administrator (H), Clinical Coordinator (G) and Manager of Clinical Safety (J) confirmed Patient #s 2, 4, 5, 6 and 10 did not receive their hemodialysis treatments as prescribed for the dates in question.”

“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: 48020 Based on observation, record review and interview, the direct care staff failed to: wear personal protective equipment while preparing 1:10 and 1:100 bleach disinfection containers according to policy. B) implement facility’s policy and procedure when opening a new bottle of conductivity or pH solution. C) Based on observation, record review and interview the facility’s registered nurses failed to conduct assessments when patients experienced a change in condition before or after the hemodialysis treatment per the facility’s policy in 2 of 12 sampled and closed patients: Patient #s 5, 10 Findings: Review of the facility’s policy and procedure on Infection Control For Dialysis Facilities directs staff as follows: “PPE (i.e., gown, gloves, eye protection, face shield) 5. Appropriate PPE will be worn whenever there is potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care areas ...” Review of the facility’s current policy and procedure on Phoenix XL Meter Disinfection, Calibration Verification and Storage Procedures, Procedure: 1-21-13, directs staff as follows: “NOTES: “ When a new bottle of conductivity or pH solution is opened, label with date opened and initials of the teammate that opened a new bottle of solution. Follow manufacturer’s labeling for expiration dates.” Review of the facility’s current policy and procedure on Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, Policy 1-03-08, directs staff as follows: “POLICY: PRE-TREATMENT DATA COLLECTION/ASSESSMENT 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. 13. All findings, interventions and patient response will be documented in the patient’s medical record. POST TREATMENT DATA COLLECTION/ASSESSMENT 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. ABNORMAL FINDINGS Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre-dialysis: o Systolic greater than 180 mm/Hg or less than 90 mm/Hg o Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg Blood Pressure Post Treatment: o If the patient can stand: o Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg o Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg o If patient is not able to stand, document reason and sitting BP o Sitting BP for patient’s that cannot stand: o Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg o Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg” Bleach Station Observation on 01/15/2025 at 7:08 a.m. revealed Patient Care Technician (E) preparing the 1:10 and 1:100 bleach disinfection solutions at the nursing station nearest the laboratory. Patient Care Technician (E) was wearing her personal glasses and a face mask but her goggles were hanging around her neck during the bleach preparation process. Interview with Patient Care Technician (E) on 01/15/2025 at 07:28 a.m. confirmed that she should have been wearing her goggles over her glasses while preparing the 1:10 and 1:100 bleach solutions for disinfection. Conductivity Meter Station Observation of the Conductivity Solution Station on 01/15/2025 at 7:28 a.m. revealed a bottle of MesaLabs Combined Standard Solution (pH Buffer Solution with Standardized Conductivity) 14.0 mS/cm Conductivity / 7.0 pH. The label on the bottle directs the staff to “Discard 30 days after opening”. The bottle was almost empty and had no open or discard date documented on it to determine 30 days from opening. Interview with Patient Care Technician (E) on 01/15/2025 at 7:30 a.m. confirmed the facility uses the combined standard solution for the calibration of their Phoenix meters and that the open and discard date should have been written on the bottle. Assessments Patient #5 On 01/15/2025 at 7:41 a.m. Patient #5 was observed on the treatment floor of the facility at station #13 machine #14. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a left upper arm vascular access. Review of the patient’s clinical record on 01/16/2025 revealed the following: Treatment sheet review: Review of the patient’s treatment sheet dated 01/15/2025 revealed the following documentation: 08:32 a.m.: documented blood pressure of 147/39 mmHg and pulse rate of 55 beats per minute - patient care technician documented “Patient appears to be tolerating treatment well at this time; retaking b/p” 08:43 a.m.: documented blood pressure of 99/32 mmHg and pulse rate of 57 beats per minute - patient care technician documented “Patient awake; alert; and states no complaints at this time; UF OFF DBP LOW RN notified” 09:03 a.m.: documented blood pressure of 181/40 mmHg and pulse rate of 55 beats per minute - patient care technician documented “Patient face; vascular access; and blood line connections visible; Patient monitored eyes closed; patient resting; 0pt bp diastolic low uf remains off.” 09:13 a.m.: the registered nurse documented “bp trending up w/low dbp; pt remains asymptomatic; UF on will continue to monitor” 09:32 a.m.: documented blood pressure of 181/50 mmHg and pulse rate of 54 beats per minute 10:02 a.m.: documented blood pressure of 123/36 mmHg and pulse rate of 60 beats per minute 10:04 a.m.: documented blood pressure of 139/59 mmHg and pulse rate of 66 beats per minute 10:32 a.m.: documented blood pressure of 113/29 mmHg and pulse rate of 60 beats per minute 10:34 a.m.: documented blood pressure of 126/42 mmHg and pulse rate of 59 beats per minute 10:54 a.m.: documented blood pressure of 105/31 mmHg and pulse rate of 59 beats per minute 10:55 a.m.: registered nurse documented the post-treatment assessment which revealed the following comments: “N/A” despite the patient’s post-treatment sitting blood pressure of 185/88 sitting. Patient #10 Review of the patient’s clinical record on 01/16/2025 revealed the patient was admitted to facility on 03/08/2011. The patient had diagnoses of end-stage renal disease, cerebrovascular accident, hypertension, hyperlipidemia, type 2 diabetes mellitus, vascular stent, pulmonary vascular congestion, on three times a week hemodialysis. Review of the patient’s clinical record on 01/16/2025 revealed the following: Treatment sheet review: Review of treatment sheet dated 01/15/2024 revealed the following documentation: 05:46 a.m.: Pretreatment vital signs: blood pressure of 192/88 sitting, pulse of 90 beats per minute. 06:05 a.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 183/86 and pulse rate of 84 beats per minute - patient care technician documented “Normal saline prime given. Treatment started without complications; Patient awake; alert; and states no complaints at this time.” There was no documentation about reporting the abnormal systolic blood pressure greater than 180 mm/Hg to the licensed nurse. 06:31 a.m.: documented blood pressure of 166/80 mmHg and pulse rate of 78 beats per minute - patient care technician documented “Patient awake; alert; and states no complaints at this time” 07:00 a.m.: registered nurse documented the pretreatment assessment which revealed the following comments: “UFG set at 1.8 Kg as tolerated. RR-18. No acute distress noted.” There was no mention of the abnormal systolic blood pressure greater than 180 mm/Hg found during the pre-treatment vitals at 05:46 a.m. 07:01 a.m.: documented blood pressure of 161/75 mmHg and pulse rate of 75 beats per minute - patient care technician documented “Patient appears to be tolerating treatment well at this time Patient face; vascular access; and blood line connections visible” 07:31 a.m.: documented blood pressure of 149/73 mmHg and pulse rate of 81 beats per minute - patient care technician documented “Patient appears to be tolerating treatment well at this time Patient face; vascular access; and blood line connections visible” 08:01 a.m.: documented blood pressure of 145/74 mmHg and pulse rate of 80 beats per minute - patient care technician documented “Patient appears to be tolerating treatment well at this time” 08:31 a.m.: documented blood pressure of 155/65 mmHg and pulse rate of 74 beats per minute - patient care technician documented “Patient monitored; watching tv no complications; Patient face; vascular access; and blood line connections visible” 09:01 a.m.: documented blood pressure of 130/59 mmHg and pulse rate of 78 beats per minute - patient care technician documented “Patient appears to be tolerating treatment well at this time Patient face; vascular access; and blood line connections visible” 09:03 a.m.: the registered nurse documented “BP improved; pt tolerating tx well” 09:21 a.m.: documented blood pressure of 150/67 mmHg and pulse rate of 73 beats per minute - patient care technician documented “Treatment terminated” The licensed nurse did not assess the patient’s blood pressure prior to the initiation of the hemodialysis treatment at 05:46 a.m. The licensed nurse documented a note on the blood pressure at 09:03 a.m., which was 18 minutes prior to the end of the hemodialysis treatment. Interview during record review on 01/16/2025 at 12:35 p.m. with Facility Administrator (H), Clinical Coordinator (G) and Manager of Clinical Safety (J) confirmed Patient #s 5 and 10 did not receive an assessment by the licensed nurse as required by the policy for the dates in question.”