Davita Comprehensive Renal Care - Munster

“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: 51199 Based on record review and interview, the dialysis facility failed to notify the state agency, the Indiana Department of Health, when their emergency management plan was activated due to a data breech that compromised electronic medical records [EMR], patient health information, and patient personal information. Findings include: 1.A revised policy, dated October 2024, titled “Facility Emergency Management Plan” indicated that the Facility Administrator [FA] is responsible to maintain communication during an emergency event with the State survey agency. 2.During an interview on 04/23/2025, beginning at 9:50AM, the FA indicated that there was a data breech on 04/12/2025, compromising the EMR and patient personal information and the facility currently has limited access to EMR while the emergency action plan has been activated. The FA admitted that the Indiana Department of Health was not notified of the event.”

“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: 51199 Based on record review, observation, and interview, the dialysis facility failed to ensure that the PCT removed dirty gloves, performed hand hygiene, and donned new gloves in 1 of 2 observations of accessing an arteriovenous fistula [AVF] (access for hemodialysis) for initiation of dialysis and in 1 of 2 observations of discontinuation of dialysis with a central venous catheter [CVC] (catheter into vein). Findings include: 1. A revised policy, dated April 2023, titled “Infection Control for Dialysis Facilities” indicated that hand hygiene should be performed prior to gloving and immediately after removal of gloves, after patient contact, and after dialysis delivery contact. 2. During an observation on 04/23/2025, beginning at 10:45AM, at station #13, PCT 1 located and palpated the AVF cannulation site and failed to remove dirty gloves, perform hand hygiene, and don new gloves prior to disinfecting the cannulation sites. 3. During an observation on 04/28/2025, beginning at 10:03AM, at station #14, PCT 1 reinfused the extracorporeal circuit and disconnected the patient from the hemodialysis [HD] (a process to fileter the blood in a patient whose kidneys do not work normally) machine. PCT 1 failed to remove dirty gloves, perform hand hygiene, or don clean gloves after reinfusing the corporeal circuit and prior to disconnecting the patient from the HD machine. 4. During an interview on 04/28/2025, beginning at 2:42PM, PCT 1 indicated that hand hygiene should be performed between touching the HD machine and patients.”

“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: 51199 Based on record review, observation, and interview, the dialysis facility failed to ensure patient safety by ensuring patients hemodialysis [HD] (a process to filter the blood of a patient whose kidneys do not work normally) access sites were visible during HD treatment in 2 of 3 observation periods of in-center HD treatment. Findings include: 1. A revised policy, dated April 2024 and titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” indicated that the vascular access site and blood line connections should be visible throughout the dialysis treatment. 2. During an observation of the treatment floor on 04/25/2025, beginning at 2:50 PM, ending at 3:40 PM, Patient 14 was in station #1 with a blanket completely covering their dialysis access site. 3. During an observation of the treatment floor on 4/28/2025, beginning at 9:22 AM, Patient 19 was at station #23, and had a blanket completely covering their dialysis access site, until he/she was disconnected from the HD machine at 9:56 AM. 4. During an observation of the treatment floor on 04/28/2025, beginning at 9:27 AM and ending at 10:20 AM, Patient 20 was at station #17, they had a blanket completely covering their dialysis access site. 5. During an interview, on 04/28/2025 beginning at 1:51 PM, RN 3 indicated that dialysis access sites need to always be visible for patient safety. 6. During an interview, on 4/28/2025 beginning at 2:42 PM, PCT 1 indicated that dialysis access sites should always be visible to staff and if a patient refused, the RN should be notified.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 51199 Based on record review and interview, the dialysis facility failed to ensure PCT’s administered the correct hemodialysis [HD] (a process to clean the blood of a patient whose kidneys do not work normally) prescription in 6 of 7 in-center hemodialysis clinical record reviews and 2 of 5 in-center verifications of dialysis treatment prescription delivery. Findings include: 1. A revised policy, dated April 2024, titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” indicated that prescription and machine settings (including dialysate flow rate [DFR]) should be verified prior to initiation of treatment, and if the dialysis prescription is not being met, the reason will be documented and the licensed nurse informed. 2. During a clinical record review on 4/28/2025, for Patient 6, the following Treatment Detail Reports indicated the following: A. On 04/07/2025, the prescribed DFR was 800 milliliters per minute [ml/min] a. The DFR administered was 510ml/min at 11:08AM b. The DFR administered was 500 ml/min at 11:09AM B. On 04/14/2025, the prescribed DFR was 800ml/min a. The DFR administered was 600ml/min at 11:38AM b. The DFR administered was 650ml/min at 11:40AM C. On 04/18/2025, the prescribed DFR was 800ml/min a. The DFR administered was 620ml/min at 11:21AM 3. During a clinical record review on 04/28/2025, for Patient 5, the following Treatment Detail Reports indicated the following: A. On 03/28/2025, the prescribed DFR was 800ml/min a. The DFR administered was 620ml/min at 11:33AM B. On 04/14/2025, the prescribed DFR was 800ml/min a. The DFR administered was 600ml/min at 12:01PM b. The DFR administered was 610ml/min at 12:04PM c. The DFR administered was 600ml/min at 12:13PM d. The DFR administered was 610ml/min at 12:42PM e. The DFR administered was 610ml/min at 1:12PM f. The DFR administered was 600ml/min at 1:17PM C. On 04/16/2025, the prescribed DFR was 800ml/min a. The DFR administered was 610ml/min at 11:24AM b. The DFR administered was 610ml/min at 11:25AM 4. During a clinical record review on 04/28/2025, for Patient 7, the following Treatment Detail Reports indicated the following: A. On 04/09/2025, the prescribed DFR was 800ml/min a. The DFR administered was 510ml/min at 3:22PM b. The DFR administered was 510ml/min at 3:24PM 5. During a clinical record review on 03/28/2025, for Patient 8, the following Treatment Detail Reports indicated the following: A. On 04/23/2025, the prescribed DFR was 600ml/min a. The DFR administered was 700ml/min at 10:28AM b. The DFR administered was 710ml/min at 10:35AM c. The DFR administered was 710ml/min at 10:58AM d. The DFR administered was 700ml/min at 11:28AM e. The DFR administered was 710ml/min at 11:58AM f. The DFR administered was 710ml/min at 12:28PM g. The DFR administered was 700ml/min at 12:58PM h. The DFR administered was 710ml/min at 1:01PM 5. During a clinical record review on 03/28/2025, for Patient 10, the Treatment Detail Reports indicated the following: A. On 04/02/2025, the prescribed DFR was 500ml/min a. The DFR administered was 620ml/min at 12:20PM b.The DFR administered was 620ml/min at 12:50PM c. The DFR administered was 600ml/min at 1:20PM d. The DFR administered was 600ml/min at 1:50PM e. The DFR administered was 620ml/min at 2:20PM f. The DFR administered was 590ml/min at 3:20PM g. The DFR administered was 580ml/min at 3:50PM 6. During a clinical record review on 03/28/2025, for Patient 1, the Treatment Detail Reports indicated the following: A. On 04/08/2025, the prescribed DFR was 500ml/min a. The DFR administered was 620ml/min at 8:53AM b. The DFR administered was 610ml/min at 9:23AM c. The DFR administered was 600ml/min at 9:53AM d. The DFR administered was 600ml/min at 10:23AM e. The DFR administered was 600ml/min at 10:53AM f. The DFR administered was 600ml/min at 11:23AM g. The DFR administered was 600ml/min at 11:53AM h. The DFR administered was 600ml/min at 12:23PM 7. During an observation on 04/25/2025, at 3:30PM, Patient 15 had a prescribed DFR of 500ml/min. The HD machine was programmed and running the DFR at 700ml/min. 8. During an observation on 04/28/2025, beginning at 9:19AM, Patient 18 had a prescribed DFR of 600ml/min. The HD machine was programmed and running the DFR at 800ml/min. 9. During an interview on 04/28/2025, beginning at 1:51PM, RN 3 indicated that the DFR prescription should match what is programmed into the machine, and there is no reason it should be different without a new order. 10. During an interview on 04/28/2025, beginning at 2:42PM, PCT 1 indicated that there should be no reason that the programmed DFR does not match the prescribed DFR.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 51199 Based on interview and record review, the dialysis facility failed to provide evidence that PCT 2 passed a color-blindness test to ensure PCT 2’s ability to accurately interpret colors on test strips in 1 of 3 personnel record reviews. Findings include: 1. A revised policy, dated October 2017, titled “Color Vision Evaluation” indicated that employees who will be utilizing test kits or strips that rely on color differentiation for test results will be evaluated for ability to see color at the time of hire, and that only employees who can discern colors will perform testing with a strip or kit. 2. During a personnel record review on 04/23/2025, the dialysis facility presented a color-blindness test, dated 07/28/2010, with results indicating a color vision defect for PCT 2. 2. During a review of daily waterlog’s and chlorine logs on 04/24/2025, it was noted that PCT 2 performed water testing that included reading test strips on multiple days in February 2025, March 2025, and April 2025 4. During an interview on 04/24/2025, beginning at 2:15 PM, The Facility Manager denied knowledge of PCT 2 color vision defect and admitted that PCT 2 regularly performs water testing that relies on color test strip results.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 51199 Based on record review, observation, and interview, the dialysis facility failed to maintain accurate medical record in 3 of 3 clinical record reviews of a patient whose access was not visible during treatment floor observations. Findings include: 1. A revised policy, dated April 2024, titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” indicated that treatment monitoring includes assessment and documentation that the vascular access site and blood line connections are visible throughout the dialysis treatment. 2. During an observation of the treatment floor on 04/25/2025, beginning at 2:50 PM and ending at 3:40 PM, Patient 14 at station #1, had a blanket completely covering dialysis access site. A Treatment Details Report, dated 04/25/2025, indicated Patient #14’s Dialysis access site was visible at 2:58 PM and documented their access site was visible at 3:28 PM. 3. During an observation of the treatment floor on 4/28/2025, beginning at 9:22 AM, Patient 19 was at station #23, had a blanket completely covering dialysis access site until he/she was disconnected from the HD machine at 9:56AM. The Treatment Details Report, dated 04/28/2025, for Patient 19, indicated their dialysis access site was visible at 9:43 AM and was visible at 9:54 AM. 4. During an observation of the treatment floor on 04/28/2025, beginning at 9:27 AM and ending at 10:20 AM, Patient 20, at station #17, had a blanket completely covering dialysis access site. A Treatment Details Report, dated 04/28/2025, for Patient 20, indicated the following: a. Dialysis access site was visible at 9:45AM b. Dialysis access site was visible at 10:15AM 5. During an interview on 4/28/2025, beginning at 2:42 PM, PCT 1 indicated that dialysis access sites should always be visible to staff and if a patient refused, then it should be documented and RN should be notified.”