Davita Northstar Dialysis Center

“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: 48020 Based on observation, interview and record review: the facility failed to ensure patient’s nephrologist round and assess patient’s every two weeks in 2 of 19 sampled patients: Patient #s 4, 13 B) the facility’s Medical Director failed to ensure all direct care staff providing hemodialysis treatment to patients complete the annual competency examination in 6 of 8 direct care staff observed: Registered Nurse (B), (S), (G) and Patient Care Technician (C), (aa), (W) Findings: Physician Rounding Patient #4 On 01/27/2025 at 7:20 a.m. Patient #4 was observed at station #31 hemodialysis machine #56 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and ultrafiltration rate of 177 mL/min via a right upper arm vascular access. Review of the patient’s clinical record revealed physician progress note dated 10/04/2024, 11/08/2024, 12/18/2024 and 1/12/2025. There was no documented physician progress note every two weeks as required by the state regulations. Patient #13 Review of the patient’s clinical record on 01/28/2025 revealed the patient was admitted to the facility on 05/25/2023 with diagnosis of end stage renal disease, hypertension, and acute heart failure, on in-center hemodialysis three times weekly. Review of the patient’s clinical record revealed physician progress note dated 09/12/2024, 09/17/2024, 11/21/2024 and 12/20/2024. There was no progress note documented by the physician for October 2024. The facility’s hospitalization log revealed the patient was hospitalized from 01/03/2025- 01/10/2025. There was no documented physician progress note every two weeks as required by the state regulations. Interview during record review on 01/28/2025 at 2:35 p.m. with Manager of Clinical Safety (I) confirmed the above findings. Competency Examinations Charge Nurse (B) Observation of the hemodialysis treatment area on 01/27/2025 revealed Charge Nurse (B) at the medication station drawing up medications to dispense to patients. Review of the facility’s Teammate Schedule revealed Charge Nurse (B) was scheduled to provide care and services to hemodialysis patients on various days in October 2024 and December 2024. Registered Nurse (S) Observation of the hemodialysis treatment area on 01/27/2025 revealed Registered Nurse (S) providing care and services to hemodialysis patients. Review of the facility’s Teammate Schedule revealed Registered Nurse (S) was scheduled to provide care and services to hemodialysis patients on various days in October 2024, November 2024 and December 2024. Registered Nurse (S) was scheduled to work as the charge nurse on certain days during October - December 2024. Registered Nurse (G) Observation of the hemodialysis treatment area on 01/27/2025 revealed Registered Nurse (G) providing care and services to hemodialysis patients. Review of the facility’s Teammate Schedule revealed Registered Nurse (G) was scheduled to provide care and services to hemodialysis patients on various days in October 2024, November 2024 and December 2024. Patient Care Technician (C) Observation of the hemodialysis treatment area on 01/27/2025 revealed Patient Care Technician (C) providing care and services to hemodialysis patients. Review of the facility’s Teammate Schedule revealed Patient Care Technician (C) was scheduled to provide care and services to hemodialysis patients on various days in October 2024, November 2024 and December 2024. Patient Care Technician (aa) Observation of the hemodialysis treatment area on 01/27/2025 revealed Patient Care Technician (aa) providing care and services to hemodialysis patients. Review of the facility’s Teammate Schedule revealed Patient Care Technician (aa) was scheduled to provide care and services to hemodialysis patients on various days in October 2024, November 2024 and December 2024. Patient Care Technician (W) Observation of the hemodialysis treatment area on 01/28/2025 revealed Patient Care Technician (W) providing care and services to hemodialysis patients. Review of the facility’s Teammate Schedule revealed Patient Care Technician (W) was scheduled to provide care and services to hemodialysis patients on various days in October 2024, November 2024 and December 2024. Review of the ESRD CORE SURVEY FACILITY WORKSHEET: PERSONNEL FILE on 01/28/2025 revealed the following documentation: Staff ID Hire Date/ Orientation Competency Exam Due Date B 11/25/2013 08/18/2024 S 08/20/2018 08/18/2024 G 08/23/2022 10/21/2023 W 06/15/2015 08/21/2024 C 10/15/2015 08/13/2024 aa 05/22/2023 08/20/2024 Interview on 01/28/2025 at 14:30 p.m. with Manager of Clinical Safety (I) confirmed the competency examination due dates were correct on the worksheet and that the competency examinations were expired.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48020 Based on observation, interview and review the facility’s direct care staff failed to: prevent cross contamination by storing several chairside computer carts in between hemodialysis machines in use. B) prevent cross contamination by storing a trash receptacle in between the Hoyer Lift and a wheelchair. C) maintain clean bottles and bottle holders for the reverse osmosis (RO) water (dialysis quality water) used to rinse the Phoenix meters after checking the conductivity pH values of the dialysate on the hemodialysis machines. Findings: Review of the facility’s current policy and procedure: Infection Control for Dialysis Facilities, Policy 1-05-01, directs the staff as follows: “DISINFECTION 15. The chair side cart, terminals mounted on the counter, monitor and keyboard are considered clean areas. FACILITY HYGIENE 16. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled.” Chairside Carts Observation of the hemodialysis treatment area on 1/27/2025 at 7:13 a.m. revealed several chairside computer carts stored in between hemodialysis machines in use at stations #s 21- 22 and 23-24. Interview during the walkthrough with the Manager of Clinical Safety (I) at 10:35 a.m. confirmed the findings. Subsequent observation of the hemodialysis treatment area on 1/28/2025 at 7:05 a.m. revealed chairside computer carts stored in between hemodialysis machines in use at stations #s 26-27 and 28-29. The Surveyor notified Patient Care Technician (bb) during an interview at 7:25 a.m. that she failed to prevent cross contamination by storing several chairside computer carts in between hemodialysis machines in use. Patient Care Technician (bb) said, “The computers are considered dirty and should be wiped down after each patient.” Hoyer Lift Observation of the hemodialysis treatment area on 1/27/2025 at 7:25 a.m. revealed a large trash receptacle with trash in it stored in between the Hoyer Lift and one of the facility’s wheelchair in POD 1 West. Interview with the Patient Care Technician (C) during the observation confirmed the above findings and that the Hoyer Lift was used on a patient the morning of the survey. RO Bottles and Holders Observation of the hemodialysis treatment area on 1/27/2025 at 10:27 a.m. revealed a bottle labeled RO Water (dialysis quality water) draining into the dirty sink of each POD. The RO Water is used to rinse the Phoenix meters after checking the conductivity and pH values of the dialysate on the hemodialysis machines. The bottles had several strips of tape and tape residue on them and the bottle holders had dust collected on them. Interview during the walkthrough with the Manager of Clinical Safety (I) at 10:35 a.m. confirmed the findings.”

“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: 48020 Based on observation, interview and record review the facility’s direct care staff failed to: clean and disinfect stethoscopes, emergency disconnect bags, laminates hanging on the intravenous poles, back of the hemodialysis machines, wall boxes, water lines and chase cabinets behind the dialysis stations in 1 of 6 staff observed: Patient Care Technician (D) B) prevent cross contamination by wiping the wall boxes and using the same gloves to pick up clean bleach towels to wipe the blood pressure cuff and hemodialysis chair 1 of 6 staff observed: Patient Care Technician (E) C) prevent cross contamination by wiping the wall boxes and using the same towel to wipe the back of the hemodialysis machine in 1 of 6 staff observed: Patient Care Technician (F) D) ensure that infection control was maintained as evidenced by chase cabinet countertops with tape and tape residue on them in 4 of 48 stations observed. E) ensure that infection control was maintained as evidenced by hemodialysis chair side tables that had tape and tape residue. (20 of 44 chairs) Findings: Review of the facility’s current policy and procedure: Infection Control for Dialysis Facilities, Policy 1-05-01, directs the staff as follows: DISINFECTION 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system ...” Patient Care Technician (D) Station #35 Observation on 01/27/2025 at 9:35 a.m. revealed Patient Care Technician (D) terminally cleaning station #35 post hemodialysis treatment of a patient. Patient Care Technician (D) failed to clean and disinfect the dialyzer holder, stethoscope, emergency disconnect bag and laminates hanging on the intravenous pole, back of the hemodialysis machine, chase cabinet and wall box. The Surveyor immediately notified Patient Care Technician (D) that he failed to clean and disinfect the dialyzer holder, stethoscope, emergency disconnect bag and laminates hanging on the intravenous pole, back of the hemodialysis machine, chase cabinet and wall box. at stations #35. Patient Care Technician (D) said, “Okay, I’ll clean them.” Patient Care Technician (E) Station #23 Observation on 01/27/2025 at 10:17 a.m. revealed Patient Care Technician (E) terminally cleaning station #23 post hemodialysis treatment of a patient. Patient Care Technician (E) failed to prevent cross contamination by wiping the wall boxes and using the same gloves to pick up clean bleach towels to wipe the blood pressure cuff and hemodialysis chair. The Surveyor notified Patient Care Technician (E) at 10:20 a.m. that he failed to prevent cross contamination by wiping the wall boxes and using the same gloves to pick up clean bleach towels to wipe the blood pressure cuff and hemodialysis chair. Patient Care Technician (E) said, “Okay.” Patient Care Technician (O) Station #21 Observation on 01/28/2025 at 9:57 a.m. revealed Patient Care Technician (O) terminally cleaning station #31 post hemodialysis treatment of a patient. Patient Care Technician (O) failed prevent cross contamination by wiping the wall boxes and using the same towel to wipe the back of the hemodialysis machine. Station #34 subsequent observation at 11:02 a.m. revealed Patient Care Technician (O) terminally cleaning station #34 post hemodialysis treatment of a patient. Patient Care Technician (O) failed prevent cross contamination by wiping the wall boxes and using the same towel to wipe the back of the hemodialysis machine and the dialysate lines. The Surveyor immediately notified Patient Care Technician (O) that she failed to prevent cross contamination by wiping the wall boxes and using the same towel to wipe the back of the hemodialysis machines and the dialysate lines. Patient Care Technician (O) said, “Yes ma’am, okay.” Observation of the hemodialysis treatment area on 01/27/2025 at 7:39 a.m. revealed: dirty pieces of tape and tape residue on the countertop of the chase cabinets at station #s 35, 39, 40 and 41. B) tape and tape residue on the tray tables and arms of the hemodialysis chairs at station #s 1, 2, 4, 9, 13. Interview during the walkthrough with the Manager of Clinical Safety (I) at 10:35 a.m. confirmed the findings. 37492 Observation of the clinic chairs revealed that the chairs had multiple pieces of tape and tape residue on the sides and top of table (20 out of 44 chairs). Interview on 1/27/25 with the employee (#I) Manager of clinical safety revealed that she is aware of the issue.”

“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 2 of 19 sampled and closed patients: Patient #s 1, 2 B) the facility failed to ensure that the doctor’s orders for dialysate temperature were followed by accurately setting the temperature for the administration of dialysate in 20 of 60 treatment sheets reviewed. 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 #1 On 01/27/2025 at 7:10 a.m. Patient #1 was observed on the treatment floor of the facility at station #28 machine #46. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and ultrafiltration rate of 575 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a left upper arm vascular access. Treatment sheet review: Blood Flow Rate Review of the patient’s treatment sheet dated 01/15/2025 revealed the Dialysis Prescription Blood Flow Rate of 350 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 300 mL/min from 7:03 a.m. - 10:25 a.m. There was no justification documented for the blood flow rates of 300 mL/min. Patient #2 On 01/27/2025 at 7:13 a.m. Patient #2 was observed on the treatment floor of the facility at station #29 machine #10. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and ultrafiltration rate of 600 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a left upper arm vascular access. Treatment sheet review: Blood Flow Rate Review of the patient’s treatment sheet dated 01/17/2025 revealed the Dialysis Prescription Blood Flow Rate of 400 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 350 mL/min from 8:32 a.m. - 9:20 a.m. There was no justification documented for the blood flow rates of 350 mL/min. Review of the patient’s treatment sheet dated 01/15/2025 revealed the Dialysis Prescription Blood Flow Rate of 400 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 350 mL/min from 7:04 a.m. - 9:22 a.m. There was no justification documented for the blood flow rates of 350 mL/min. 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 194 min (3h 14m) 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. Treatment Temperature Review of treatment sheets revealed the following patients did not receive their hemodialysis treatment at the prescribed dialysate temperature: Date Time Patient Ordered Actual Machine Verified # Temp Temp Set Up By 01/20/25 11:27 7 35.5 37.0 M L 01/24/25 06:16 7 35.5 37.0 O N 01/17/25 06:50 7 35.5 37.0 P N 01/10/25 06:12 7 35.5 37.0 N N 01/19/25 06:25 7 35.5 37.4 Q R 01/22/25 12:11 8 35.0 37.0 T S 10/24/24 06:25 11 37.0 36.0 V N 10/31/24 06:54 11 37.0 36.0 V N 11/02/24 06:12 11 37.0 36.0 V N 01/27/25 07:11 4 36.0 37.0 M B 01/19/25 06:15 10 36.0 37.0 O B 01/13/25 05:58 5 36.0 37.0 Y X 01/15/25 06:10 5 36.0 37.0 Y X 01/17/25 06:06 5 36.0 37.0 Y X 01/19/25 05:57 5 36.0 37.0 Y B 01/22/25 11:44 5 36.0 37.0 Y B 01/24/25 06:01 5 36.0 37.0 Y Z 01/27/25 05:57 5 36.0 37.0 Y B 01/17/25 05:38 2 36.0 37.0 aa X 04/16/24 06:32 18 37.0 36.0 Z L Interview during record review on 01/28/2025 at 2:45 p.m. with Manager of Clinical Safety (I) confirmed the patients 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 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 19 sampled and closed patients: Patient #s 1, 2 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: 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 Heart or Pulse Rate Pre/Intra/Post: o Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat Patient #1 On 01/27/2025 at 7:10 a.m. Patient #1 was observed on the treatment floor of the facility at station #28 machine #46. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and ultrafiltration rate of 575 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: 06:16 a.m.: documented blood pressure of 115/57 mmHg and pulse rate of 56 beats per minute - PCT documented “Treatment started without complications.” 06:37 a.m.: registered nurse documented the pre-treatment assessment which revealed the documented blood pressure of 118/62 mmHg and pulse rate of 55 beats per minute. 07:03 a.m.: documented blood pressure of 110/56 mmHg and pulse rate of 57 beats per minute - PCT documented “Patient awake; alert; and states no complaints at this time.” 07:31 a.m.: documented blood pressure of 128/65 mmHg and pulse rate of 46 beats per minute - PCT documented “Patient face; vascular access; and blood line connections visible.” 08:02 a.m.: documented blood pressure of 114/54 mmHg and pulse rate of 49 beats per minute - “Patient appears to be tolerating treatment well at this time.” 08:31 a.m.: documented blood pressure of 131/69 mmHg and pulse rate of 54 beats per minute - PCT documented “Patient awake; alert; and states no complaints at this time.” 09:01 a.m.: documented blood pressure of 111/59 mmHg and pulse rate of 53 beats per minute - PCT documented “Patient monitored eyes closed; patient resting.” 09:31 a.m.: documented blood pressure of 114/54 mmHg and pulse rate of 50 beats per minute - PCT documented “Patient awake; alert; and states no complaints at this time.” 10:01 a.m.: documented blood pressure of 115/49 mmHg and pulse rate of 57 beats per minute - PCT documented “dbp trending down low; will cont to monitor for now; RN notified.” 10:25 a.m.: documented blood pressure of 100/58 mmHg and pulse rate of 57 beats per minute - PCT documented “Treatment terminated” 11:00 a.m.: registered nurse documented the post-treatment assessment which revealed the documented blood pressure of 121/58 mmHg and pulse rate of 59 beats per minute. There was no mention of the abnormal heart rate and diastolic blood pressure that the patient experienced during treatment. Treatment sheet review: Review of the patient’s treatment sheet dated 01/13/2025 revealed the following documentation: 06:29 a.m.: documented blood pressure of 100/52 mmHg and pulse rate of 61 beats per minute - PCT documented “Treatment started without complications.” 06:48 a.m.: registered nurse documented the pre-treatment assessment which revealed the documented blood pressure of 122/57 mmHg and pulse rate of 62 beats per minute. 07:01 a.m.: documented blood pressure of 98/53 mmHg and pulse rate of 52 beats per minute - PCT documented “Patient awake; alert; and states no complaints at this time.” 07:16 a.m.: documented blood pressure of 102/52 mmHg and pulse rate of 45 beats per minute - PCT documented “Rechecked patient BP; patient alert.” 07:31 a.m.: documented blood pressure of 98/55 mmHg and pulse rate of 46 beats per minute - PCT documented “Patient appears to be tolerating treatment well at this time.” 08:01 a.m.: documented blood pressure of 107/54 mmHg and pulse rate of 65 beats per minute - PCT documented “Patient monitored; watching tv no complications.” 8:31 a.m.: documented blood pressure of 100/48 mmHg and pulse rate of 61 beats per minute - PCT documented “patient dbp trending down; monitoring at this time.” 09:01 a.m.: documented blood pressure of 106/53 mmHg and pulse rate of 57 beats per minute - PCT documented “Patient awake; alert; and states no complaints at this time.” 09:31 a.m.: documented blood pressure of 92/52 mmHg and pulse rate of 55 beats per minute - PCT documented “Patient appears to be tolerating treatment well at this time.” 10:01 a.m.: documented blood pressure of 92/52 mmHg and pulse rate of 55 beats per minute - PCT documented “retaking bp; late entry.” 10:06 a.m.: documented blood pressure of 114/53 mmHg and pulse rate of 48 beats per minute - PCT documented “late entry; patient alert and stable; HR trending low; RN notified.” 10:31 a.m.: documented blood pressure of 150/47 mmHg and pulse rate of 50 beats per minute - PCT documented “BP improving; HR increased; patient asymptomatic; RN notified.” 10:39 a.m.: documented blood pressure of 109/49 mmHg and pulse rate of 51 beats per minute - PCT documented “Treatment terminated.” 11:00 a.m.: registered nurse documented the post-treatment assessment which revealed the documented blood pressure of 161/66 mmHg and pulse rate of 61 beats per minute. There was no mention of the abnormal heart rate and diastolic blood pressure that the patient experienced during treatment. Patient #2 On 01/27/2025 at 7:13 a.m. Patient #2 was observed on the treatment floor of the facility at station #29 machine #10. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and ultrafiltration rate of 600 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 01/28/2025 revealed the following: Treatment sheet review: 05:46 a.m.: documented blood pressure of 152/64 mmHg and pulse rate of 74 beats per minute - PCT documented “Treatment started without complications.” 05:51 a.m.: registered nurse documented the pre-treatment assessment which revealed the documented blood pressure of 136/61 mmHg and pulse rate of 68 beats per minute. 06:02 a.m.: documented blood pressure of 146/77 mmHg and pulse rate of 84 beats per minute 06:32 a.m.: documented blood pressure of 151/77 mmHg and pulse rate of 107 beats per minute - PCT documented “Patient appears to be tolerating treatment well at this time.” 07:03 a.m.: documented blood pressure of 139/51 mmHg and pulse rate of 71 beats per minute - PCT documented “Patient monitored; eye closed; patient resting.” 07:33 a.m.: documented blood pressure of 132/44 mmHg and pulse rate of 77 beats per minute - PCT documented “Patient monitored; watching tv no complications” 8:05 a.m.: documented blood pressure of 116/51 mmHg and pulse rate of 69 beats per minute - PCT documented “Patient appears to be tolerating treatment well at this time.” 08:32 a.m.: documented blood pressure of 146/57 mmHg and pulse rate of 87 beats per minute - PCT documented “Patient states no complaints at this time.” 09:02 a.m.: documented blood pressure of 156/44 mmHg and pulse rate of 73 beats per minute - PCT documented “Patient awake; alert; and states no complaints at this time.” 09:20 a.m.: documented blood pressure of 131/49 mmHg and pulse rate of 72 beats per minute - PCT documented “Treatment terminated.” 09:56 a.m.: registered nurse documented the post-treatment assessment which revealed the documented blood pressure of 171/43 mmHg and pulse rate of 68 beats per minute. There was no mention of the abnormal heart rate and diastolic blood pressure that the patient experienced during treatment. Interview during record review on 01/28/2025 at 2:45 p.m. with Manager of Clinical Safety (I) confirmed Patient #s 1 and 2 did not receive an assessment by the licensed nurse as required by the policy for the dates in question.”

“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: 30124 Based on observation, record reviews and interviews, the facility failed to provide for and monitor a sanitary environment to minimize the transmission of infectious agents. Findings in the patient treatment area: 1. Multiple patient hemodialysis chairs were observed to have tape adhered to the surface and sticky tape residue on the patient chairs and side tables. 2. Multiple portable computer stands were observed with a visible build of dust on the top lateral surfaces and bottom leg segments of the computer stands. 3. Multiple walls directly adjacent to patient’s hemodialysis station were observed to have brownish red droplet splatter on the surface. The facility currently has a census of 158 incenter patients. This deficient practice placed all patients in the facility at risk for the likelihood of harm by placing them at a risk of serious illness and possible subsequently death. Policy Reviewed: Review on 10/03/2023 of the facility’s current policy titled: “Infection Control for Dialysis Facilities”; policy: 1-05-01; Revision Date April 2023. Purpose: To minimize the spread of infections or blood borne pathogens in the dialysis environment. DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to clean/designated area or removed from the treatment area. a. Prior to routine disinfection, remove all visible blood. i. For visible blood or gross blood spills, a 1:10 bleach solution must be utilized. ii. After all visible blood is cleaned with the 1:10 bleach solution, teammates are to use a new disposable towel soaked with 1:10 bleach solution and clean the area a second time. iii. Cleaning of visible blood should be performed when first observed. 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. Pressurized washers, spray bottles, or sprayers for cleaning purposes will not be used on wall boxes or the adjoining area Teammates will monitor and address wall box residue/build up and patency issues. ii. Priming containers are to be emptied prior to disinfection. Drain line and water supply line should not be placed with ends in prime containers or in a position where they can drip into or contaminate the prime bucket. 15. The chair side cart, terminals mounted on the counter, monitors and keyboards are considered clean areas. a. Wipeable keyboard covers or medical grade keyboards are to be utilized. b. The chairside cart components will be cleaned at the end of each treatment day. E. The monitor screen is cleaned as needed and daily at end of each treatment day using a disposable wipe moistened with 65-70% isopropyl alcohol solution. Observation on the morning of 5/15/2024 along with the Facility’s Administrator staff ID #A of the patient treatment area the following infection control issues were observed: Tape and tape residue was observed on the following patient treatment chairs at station ID # 21, 22, 23, 26, 27, 28,34,and 38. The dialysis machine could not be adequately cleaned and disinfected due to the sticky tape. Rolling computer stands were observed with visible dust on computers stands between stations 34 & 35, 26 & 27, and 32 & 33. Dried droplet splatter that appeared to be brownish red in color was observed on the adjacent wall to station #s 9, 13, 38, 46 and 49. Interview with Staff ID #A confirmed the patient stations, rolling computer stands and adjacent wall surfaces had not been properly cleaned and disinfected.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 37322 Based on observation, and interview on 05/15/2024 the licensed nurse failed to do daily check for the Philip Heart Start FR2, and the Zolle Automated External Defibrillator and to ensure EAD pads were present on the emergency cart. Findings Include: Review of the facility policy “Emergency Equipment Checks, Updated April, 2024, stated the following equipment checks will be perform by a licensed nurse teammate to verify the designed equipment is available and functional. Daily: Check the status indicator light of Phillips Heart Start FR2, Check status indicator for green check for Zoll AED, Manufacturer’s EAD pads are present on the cart, Break away lock is intact. Review of the log revealed the following: Friday, February 2, 2024, the above items were not checked. Wednesday, March 13, 2024, and Friday, March 15, 2024, the above items were not checked. Monday, April 8, 2024, the above items were not checked. Interview on 05/20/2024 at 1237, with the regional director (ROD) (#E) and facility administration (FA) (#J) who both verified the findings.”

“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 record review and interview the facility’s Medical Director failed to ensure that employees followed the facility’s current policy and procedure in that : 1. Pre-nursing assessment were not completed within the first hour of initiation of hemodialysis treatment for 3 of 14 selected patient records reviewed. (Patient ID#s 8, 10, 12) . 2. Opened gallon containers of acid concentrate were not labeled with date opened and initials of teammates for 3 of 10 containers observed. Policies Reviewed: Review on 5/15/2024 of the facility’s current policy along with clinical services staff ID #B titled, “Utilizing Acid Concentrate in Containers”; Procedure 1-06-02A; Revision Date April 2023. Procedure: Upon opening an acid concentrate container, label container with date opened, and initials of teammate. Connect the dialysis delivery system acid concentrate line to the wand connector. Policy Reviewed: Review on 5/15/2024 of the facility’s current policy along with clinical services staff ID #B titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, Policy: 1-03-08; Revision Date April 2024. Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. 2. The Nursing assessment will be performed and documented by a licensed nurse; specifically, a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LVN). a. The assessment includes the following components: i. Review of the patient reports, data collection complaints and response to treatment. ii. Verification that machine safety checks have been completed and documented. iii. Verification of prescription including machine parameters. iv. Verification that the patient access is visible and face not covered. v. Review of documentation for accuracy, completion, and patient data. vi. A physical assessment of the patient which includes: 1. Apical heart rate and rhythm 2. Auscultation of the lungs 3. Evaluation of volume status including edema 4. Bruising or bleeding 5. Patient statement of well-being, level of pain or discomfort 6. And other components which if observed/informed will be documented including but not necessarily limited to: changes in normal level of consciousness, mobility or mental status, complaints of nausea, vomiting, diarrhea, constipation, skin changes, headache, respiratory distress, angina, weakness fever, cramping dizziness reports of illness and/or injuries, falls conditions/complications or other problems patient has experienced since the last dialysis treatment. 4. 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 the licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Intradialytic Data Collection/Assessment 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one hour of dialysis treatment initiation or sooner as required by state law. Observation on 05/15/2024 along with Staff ID #C the surveyor observed the following: Patient ID #8 was observed at station # 42 receiving hemodialysis treatment utilizing a Nepro hemodialysis machine. Patient was observed dialyzing on a 3.0 Potassium, 2.5 Calcium dialysate bath. The gallon container of 3.0 Potassium, 2.5 Calcium acid utilized for the treatment was not labeled with the date or the initials of the teammate that opened the container. Patient ID #11 was observed at station # 30 receiving hemodialysis treatment utilizing a Nepro hemodialysis machine. Patient was observed dialyzing on a 2.0 Potassium, 3.0 Calcium dialysate bath. The gallon container of 2.0 Potassium, 3.0 Calcium acid utilized for the treatment was not labeled with the date or the initials of the teammate that opened the container. Patient ID #14 was observed at station # 26 receiving hemodialysis treatment utilizing a Nepro hemodialysis machine. Patient was observed dialyzing on a 3.0 Potassium, 2.5 Calcium dialysate bath. The gallon container of 3.0 Potassium, 2.5 Calcium acid utilized for the treatment was not labeled with the date or the initials of the teammate that opened the container. Interview on 05/15/2024 with Staff ID #C confirmed the above finding and stated the containers should have been labeled when opened with the date and the teammate’s initials. Review on 05/16/2024 of patient records along with staff ID #B identified the following: Patient ID #8’s hemodialysis record: 05/15/2024 hemodialysis treatment initiated at 09:55 AM Pre-assessment completed at 11:55 PM Patient ID #10’s hemodialysis record: 05/06/2024 hemodialysis treatment initiated at 10:18 AM Pre-assessment completed at 11:56 PM 05/10/2024 hemodialysis treatment initiated at 10:29 AM Pre-assessment completed at 12:16 PM 05/13/2024 hemodialysis treatment initiated at 10:22 AM Pre-assessment completed at 11:45 AM Patient #12’s hemodialysis record: 05/10/2024 hemodialysis treatment initiated at 10:33 AM Pre-assessment completed at 12:15 PM Interview on 05/16/2023 at 15:00 PM with staff ID #B confirmed the initial nursing assessments were not completed within the first hour of dialysis for the above findings.”