Global Dialysis Plus Inc.

“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 3 of 6 sampled patients: Patient #s 1, 2 and 3 Findings: Patient #1 On 12/02/2024 at 7:53 AM, Patient #1 was observed on machine #A2 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and dialysate flow rate of 600 mL/min via a left lower arm vascular access. Vital signs were: Review of the patient’s clinical record (demographic record) revealed the patient was admitted to the facility on 01/19/2015 with diagnosis of end stage renal disease, hypertension and diabetes mellitus on insulin, on in-center hemodialysis three times weekly. Review of the patient’s clinical record revealed a face-to-face physician progress note dated 09/30/2024, 10/28/2024 and 11/25/2024. There was no documented face-to-face physician progress note every two weeks as required by the state regulations. Patient #2 On 12/02/2024 at 11:01 AM, Patient #2 was observed on machine #C2 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 800 mL/min via a right upper arm vascular access. Review of the patient’s clinical record (demographic record) revealed the patient was admitted to the facility on 06/22/2015 with diagnosis of end stage renal disease, hypertension, amputation, and diabetes mellitus on insulin, on in-center hemodialysis three times weekly. Review of the patient’s clinical record revealed a face-to-face physician progress note dated 09/30/2024, 10/28/2024 and 11/25/2024. There was no documented face-to-face physician progress note every two weeks as required by the state regulations. Patient #3 On 12/02/2024 at 11:20 AM, Patient #3 was observed on machine #A2 receiving hemodialysis treatment at a blood flow rate of 500 mL/min and dialysate flow rate of 800 mL/min via a left lower arm vascular access. Review of the patient’s clinical record (demographic record) revealed the patient was admitted to the facility on 06/17/2021 with diagnosis of end stage renal disease, hypertension and diabetes mellitus on insulin, on in-center hemodialysis three times weekly. Review of the patient’s clinical record revealed a face-to-face physician progress note dated 09/30/2024, 10/28/2024 and 11/25/2024. There was no documented face-to-face physician progress note every two weeks as required by the state regulations. Interview on 12/02/2024 with Facility Administrator (E) at 3:28 PM confirmed the above 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: 48020 Based on observation, record review and interview: the facility’s registered nurses failed to conduct assessments when patients experienced a change in condition during hemodialysis treatment in 3 of 6 sampled patients: Patient #s 1, 2 and 3 Findings: Review of the facility’s current policy and procedure on Patient Assessment Protocols for Hemodialysis Therapy directs staff as follows: “POLICY: A comprehensive nursing assessment will be completed prior to initiation of each hemodialysis treatment and a follow-up assessment will be performed at the end of each hemodialysis treatment. PROCEDURE “PRE-DIALYSIS” 1. Obtain pre-dialysis weight (kg). 2. Obtain vital signs: blood pressure, pulse, and temperature. 3. Physical assessment should be done including: a. Lungs sounds b. Heart tones c. Edema, fluid status d. Skin color and warmth e. Level of consciousness f. Observation of the vascular access ... 5. Notify physician of any untoward findings.” Review of the facility’s Hemodialysis Standing Orders directs staff as follows: “Intradialytic Events Hypotension NS 0.9% 250cc IV, repeat as needed up to 1,000cc Trendelenburg position, Turn UF OFF. Notify MD” Patient #1 On 12/02/2024 at 7:53 AM, Patient #1 was observed on machine #A2 receiving hemodialysis treatment at a blood flow rate of 450 mL/min and dialysate flow rate of 600 mL/min via a left lower arm vascular access. Review of the patient’s clinical record on 12/02/2024 revealed the following: Treatment sheet dated 11/29/2024: Review of treatment sheet dated 11/29/2024 revealed the following documentation: 06:00 AM: documented blood pressure of 178/83 mmHg and pulse rate of 66 beats per minute - Treatment initiated 06:30 AM - 09:30 AM the patient had no reportable vital signs or complaints 10:00 AM: documented blood pressure of 111/65 mmHg and pulse rate of 66 beats per minute 10:19 AM: documented blood pressure of 89/51 mmHg and pulse rate of 71 beats per minute - Licensed Vocational Nurse (LVN) documented, “pt’s bp low, uf off until bp stable, will monitor pt close. RN notified.” 10:30 AM: documented blood pressure of 114/64 mmHg and pulse rate of 65 beats per minute -LVN documented, “Treatment terminated - per protocol” 10:40 a.m.: Registered Nurse (RN) documented the post treatment assessment which revealed: “The goal of 5.0 liters over 4.5 hours was met. The AVF was decannulated with minimal bleeding x 10 minutes and the patient tolerated the treatment. No additional changes in the patient’s condition was documented and or reported. The patient left ambulating and was driven home by his family member.” There was no RN notification by the LVN of turning off the patient’s ultrafiltration due to hypotension. There was no RN assessment on the patient for hypotension. The RN documented in the RN Post Assessment that the patient tolerated the treatment and no additional changes in patient’s condition was documented and or reported. Patient #2 On 12/02/2024 at 11:01 AM, Patient #2 was observed on machine #C2 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 800 mL/min via a right upper arm vascular access. Review of the patient’s clinical record on 12/02/2024 revealed the following: Treatment sheet dated 11/29/2024: Review of treatment sheet dated 11/29/2024 revealed the following documentation: 10:40 AM: documented blood pressure of 130/61 mmHg and pulse rate of 66 beats per minute - Treatment initiated 10:45 AM - 12:30 PM the patient had no reportable vital signs or complaints 13:00 PM: documented blood pressure of 106/54 mmHg and pulse rate of 62 beats per minute 13:30 PM: documented blood pressure of 90/46 mmHg and pulse rate of 61 beats per minute - Licensed Vocational Nurse (LVN) documented, “pt’s bp low, pt asymptomatic, uf off until bp stable, will monitor pt close. RN notified.” 13:45 PM: documented blood pressure of 107/60 mmHg and pulse rate of 61 beats per minute - LVN documented, “pt’s bp stable, uf on.” 14:00 PM: documented blood pressure of 114/64 mmHg and pulse rate of 64 beats per minute - LVN documented, “Treatment terminated - per protocol” 10:40 AM: Registered Nurse (RN) documented the post treatment assessment which revealed: “The goal of 1.9 liters over 4.5 hours was met. The AVF was decannulated with minimal bleeding x 10 minutes and the patient tolerated the treatment. No additional changes in the patient’s condition was documented and or reported. The patient left ambulating with one legged scooter and was driven home by his family member.” The RN Post Assessment had a documented time of 10:40 AM and the patient’s treatment did not end until 14:00 PM. There was no RN notification by the LVN of turning off the patient’s ultrafiltration due to hypotension. There was no RN assessment on the patient for hypotension. The RN documented in the RN Post Assessment that the patient tolerated the treatment and no additional changes in patient’s condition was documented and or reported. Patient #3 On 12/02/2024 at 11:20 AM, Patient #3 was observed on machine #A2 receiving hemodialysis treatment at a blood flow rate of 500 mL/min and dialysate flow rate of 800 mL/min via a left lower arm vascular access. Review of the patient’s clinical record on 12/02/2024 revealed the following: Treatment sheet dated 11/29/2024: Review of treatment sheet dated 11/29/2024 revealed the following documentation: 11:00 AM: documented blood pressure of 197/123 mmHg and pulse rate of 105 beats per minute - Licensed Vocational Nurse (LVN) documented, “Treatment initiated - access visible, connections intact and tape secure.” 11:05 AM: documented blood pressure of 170/112 mmHg and pulse rate of 110 beats per minute - LVN documented, “increased blood flow rate 500ml/min.” 11:30 AM: documented blood pressure of 171/101 mmHg and pulse rate of 111 beats per minute - LVN documented, “Patient eating lunch, Treatment tolerated, bp improving.” 12:00 PM: documented blood pressure of 187/107 mmHg and pulse rate of 111 beats per minute - LVN documented, “Patient eating lunch. Treatment tolerated.” 12:30 PM: documented blood pressure of 177/105 mmHg and pulse rate of 111 beats per minute - LVN documented, “Patient access visible [sic] - connections intact and tape secure.” 13:00 PM: documented blood pressure of 166/98 mmHg and pulse rate of 111 beats per minute - LVN documented, “Patient alert and denies any c/o.” 13:30 PM: documented blood pressure of 165/108 mmHg and pulse rate of 112 beats per minute - LVN documented, “Patient resting quietly. Eyes closed. Respirations quiet and unlabored.” 14:00 PM: documented blood pressure of 178/109 mmHg and pulse rate of 111 beats per minute - LVN documented, “Patient resting quietly. Eyes closed. Respirations quiet and unlabored.” 14:30 PM: documented blood pressure of 157/104 mmHg and pulse rate of 110 beats per minute - LVN documented, “Patient access visible [sic] - connections intact and tape secure.” 15:00 PM: documented blood pressure of 182/104 mmHg and pulse rate of 110 beats per minute - LVN documented, “Pt tolerates tx, no s/s distress noted. Clonidine effective.” 15:30 PM: documented blood pressure of 174/102 mmHg and pulse rate of 118 beats per minute - LVN documented, “Treatment terminated - per protocol” There was no RN notification by the LVN of the patient’s hypertension and elevated heart rate. There was no Pre or Post RN Assessment on the patient documented for the hemodialysis treatment. Interview with Director of Nursing (A) on 12/02/2024 at 4:15 PM confirmed the RN interventions were not completed for Patient #s 1 and 3 nor was the pre and post RN assessment completed for Patient #2.”