Davita Northlake Dialysis

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 50523 Based on facility record review and staff interview, it was determined that the facility failed to provide documentation that five of nine patients (P) (P#1, P#3, P#4, P#5 and P#6) sampled, received annual emergency training and testing. This deficient practice had the potential to negatively affect the health and safety of the patients who were under the care of this facility. This facility had 87 in-center hemodialysis (ICHD) patients and eight Peritoneal Dialysis (PD) patients. Findings include: During a review of patients’ medical records, the following was revealed: - P#1 was admitted on 6/3/19. The latest emergency training and testing was dated 3/30/22. - P#3 was admitted on 4/12/22. The latest emergency training and testing was dated 4/2/22. - P#4 was admitted on 10/17/23. No emergency training and testing was documented. - P#5 was admitted on 10/24/18. No emergency training and testing was documented. - P#6 was admitted on 1/11/25. No emergency training and testing was documented. - P#1, P#3, P#4, P#5 and P#6 were diagnosed with End Stage Renal Disease (ESRD) and were receiving hemodialysis treatment three times per week. There was no documentary evidence of recent annual training and testing on the facility’s emergency policies and protocols. On 3/11/25 at 4:15 p.m. the Facility Administrator revealed that she recently had taken over the facility in October 2024. Stated that the facility was not up to date with some emergency training and testing. The Facility Administrator also stated that the next emergency training was scheduled a month out. A review of facility Policy: 4-07-01 titled, “Facility Emergency Management Plan” with latest revision date of October 2024 showed the following: Training and Education 1.The FA, or designees, is responsible to provide training... b. Patients: ANNUALLY 1. Facility specific emergency response procedures a. What to do if an emergency occurs within the facility i. Fire safety ii. Disconnection from dialysis machine iii. Emergency equipment as applicable b. Where to go if an emergency occurs, to include emergency evacuation route(s) and shelter in place location(s) (as applicable)...”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 50523 Based on a review of Fiscal Year 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by Centers for Medicare and Medicaid Services (CMS) to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), facility records, and staff interviews, it was determined that the facility failed to effectively manage patients’ nutritional status by identifying root causes and commonalities among patients who did not reach the minimum expected target of albumin (a protein in blood plasma) equal or greater than (>) 4.0 g/dL (grams per deciliter) per “CMS Measures Assessment Tool”, in six of six months of Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (August 2024 - January 2025). The facility also failed to take remedial action or adjust portions of the plan that are not successful, to maximize the number of patients who achieve the goal. Low albumin levels are highly predictive of mortality risk amongst dialysis patients. This facility had 87 in-center hemodialysis (ICHD) patients and eight Peritoneal Dialysis (PD) patients. Findings include: A review of the facility’s QAPI meeting minutes from August 2024 - January 2025, revealed no documentary evidence that the QAPI team conducted analysis of the underlying reasons for the facility’s low albumin levels for PD patients. A review of Fiscal Year 2025 QDFR revealed that 52.9% of PD patients at this facility had albumin levels of < 4 g/dL. The U.S. average was 51.8%. This facility’s average albumin of <4 g/dL for the past six months (August 2024 - January 2025) was 67% for PD. A review of this facility’s PD Albumin report from August 2024 - January 2025 revealed the following: - In August 2024, 64% of patients had Albumin levels of <4.0 g/dL. - In September 2024, 55% of patients had Albumin levels of <4.0 g/dL. - In October 2024, 92% of patients had Albumin levels of <4.0 g/dL. - In November 2024, 64% of patients had Albumin levels of <4.0 g/dL. - In December 2024, 70% of patients had Albumin levels of <4.0 g/dL; and - In January 2025, 67% of patients had Albumin levels of <4.0 g/dL. Although the facility data was collected monthly, there was no documented evidence that a root cause analysis was conducted. The plan for the last six months was to educate patients on adequate nutrition and protein intake. There was a lack of documented evidence that the interdisciplinary team modified or adjust part of the plan nor actively intervene on actionable factors. On 3/12/25 at 3:24 p.m., the Facility Administrator stated that thorough interventions will be documented to more accurately determine and address the underlying cause of each patient not meeting the goal.”

“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: 50523 Based on observations, facility record review, staff interview, and a review of facility Policy and Procedures (P&P), it was determined that the Medical Director failed to ensure that all Direct Patient Care Staff (Nurses and Patient Care Technicians), adhered to facility P&P relative to verification of dialysis prescription components for eight of 15 sampled patients’ (P) P#2, P#5 P#6, P#10, P#11, P#12, P#13, and P#14). Failure to follow and verify prescribed hemodialysis treatment orders increased the risk of not receiving adequate dialysis treatment, can lead to complications like fluid overload, electrolyte imbalances, cardiovascular problems, and fatigue, thus potentially impacting the patient’s overall health and quality of life. This facility had 87 in-center hemodialysis patients and eight peritoneal dialysis patients. Findings include: During observation in the treatment area on 3/11/25 from 10:58 a.m. through 12:20 p.m., the following was revealed: - P#2’s hemodialysis machine showed that blood flow rate (BFR) was set at 350 milliliters per min (mL/min), the bicarbonate (used as a buffer base in the dialysis fluid to help correct metabolic acidosis) was set to 38 milliequivalents per liter (mEq/L) and the base sodium was set to 138 mEq/L. P#2’s prescription revealed the following: BFR - 400 mL/min, bicarbonate - 36, and base sodium - 136 mEq/L. - P#10’s hemodialysis machine showed that dialysate flow rate (DFR) was set at 600 mL/min, and the bicarbonate was set at 36 mEq/L. P#10’s prescription revealed the following: DFR - 800 mL/min and bicarbonate - 35 mEq/L. - P#11’s hemodialysis machine showed that the bicarbonate was set at 38 mEq/L and the base sodium was set to 138 mEq/L. P#11’s prescription revealed the following: Bicarbonate - 35 mEq/L and base sodium - 136 mEq/L. - P#12’s hemodialysis machine showed that the bicarbonate was set at 35 mEq/L, yet the prescription revealed a bicarbonate of 38 mEq/L. - P#13’s hemodialysis machine showed that the BFR was set at 400 mL/min, DFR at 600 mL/min and the base sodium at 137 mEq/L. P#13’s prescription revealed the following: BFR - 350 mL/min, DFR - 800 mL/min, and base sodium - 138 mEq/L. - P#14’s hemodialysis machine showed that the DFR was set at 700 mL/min, yet the prescription revealed a DFR of 800 mL/min. There was a lack of documented rationale or reasons for not following P#2, P#10, P#11, P#12, P#13, and P#14’s prescribed BFR, DFR, bicarbonate and base sodium. A review of the “Treatment Details Report” from 2/24/25 - 3/10/25 (last six hemodialysis treatments) revealed the following: P#2: - On 2/27/25 and 3/1/25, P#2 ran the entire hemodialysis treatment with a DFR at 600 mL/min. - P#2’s prescription was for a DFR of 800 mL/min. P#5: - On 2/24/25, P#5 ran the entire hemodialysis treatment with a BFR at 350 mL/min and the DFR of 700 mL/min. - On 3/3/25, P#5 ran the entire hemodialysis treatment with a BFR at 350 mL/min. - On 3/10/25 P#5 ran the entire hemodialysis treatment with a BFR at 400 mL/min and DFR of 600 mL/min. - P#5’s prescription for BFR was 450 mL/min and the DFR was 800 mL/min. P#6: - On 2/27/25, P#6 ran the entire hemodialysis treatment with a DFR at 700 mL/min. - On 3/4/25, P#6 ran the entire hemodialysis treatment at a BFR of 350 mL/min. - On 3/8/25, P#6 ran the entire hemodialysis treatment at a BFR of 350 mL/min with a DFR of 600 mL/min. - P#6’s prescription revealed a BFR of 400 mL/min and a DFR of 800 mL/min. There was a lack of documented reasons for not dialyzing P#2, P#5, and P#6 at their prescribed BFR and DFR. On 3/13/25 at 11:30 a.m., the Facility Administrator acknowledged the above findings and stated that the facility will start to audit random patients to confirm that patient’s prescriptions are being followed. A review of facility Policy: 4-07-01 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” with latest revision date of April 2024 showed the following: 2. Patient identity, prescription, and machine settings are verified by the teammate prior to initiation of treatment with the exception of the 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 the treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: f. Blood flow rate, g. Dialysate flow rate i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented, and the licensed nurse informed.”