Davita Memorial Dialysis Center

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 14442 Based on observation, policy review, and interview, the dialysis facility failed to label isolation room hemodialysis machine as isolation machine only to ensure the machine would not be used on HBV susceptible patients. This deficient practice presented a risk to the health and safety of the 10 in-center hemodialysis HBV susceptible patients on census. Findings: Observation of the in-center hemodialysis isolation room on 04/23/2025 at 10:26 AM revealed the hemodialysis machine not labeled as isolation machine only. In an interview on 04/23/2025 at 10:27 AM, S1FA confirmed the dialysis facility had one HBsAg positive patient that was treated in the isolation room. Review of the facility “Policy: 1-05-02, Title: Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” last revised April 2024 revealed, in part: “Purpose: To prevent the spread of hepatitis B infections in the dialysis setting. Infection Control Measures for Confirmed Positive or Suspected/Unknown Status. 18 Machine. b. A designated dialysis machine, temporary or permanent, will be used for treatment in the isolation room/isolation area or station and will be labeled as an isolation machine. i. Label should read “Isolation Machine only” or “Temporary Isolation Machine.” ii. Label should be attached with adhesive and visible on the front of the machine.” In an interview on 04/23/2025 at 1:01 PM, S2MCS confirmed the hemodialysis machine in the isolation room was not labeled as per policy.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 14442 Based on observation, policy review, and interview, the dialysis facility failed to monitor and implement infection control policies within the dialysis unit. This deficient practice was evidenced by having expired blood culture kits available for use. Findings: Observation of the in-center hemodialysis laboratory supply area on 04/23/2025 at 10:41 AM revealed a Blood Culture Kit labeled with an expiration date 03/24/2025 and a Blood Culture Kit labeled with an expiration date 04/08/2025. Review of the facility “ Policy: 1-05-01, Title: Infection Control for Dialysis Facilities” last revised April 2023 revealed, in part: “Supplies 8. Supplies will be stored in a manner that maintains their integrity. b. Expiration date and package integrity will be verified prior to use.” In an interview on 04/23/2025 at 10:42 AM, S1FA confirmed the Blood Culture Kits were expired and should have been discarded.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 14442 Based on observation, policy review, and interview, the dialysis facility failed to ensure clinical staff demonstrated compliance with current aseptic techniques for intravenous medications. This deficient practice was evidenced by staff failing to label medications not immediately administered with the time prepared and initials of staff preparing the medications. Findings: Observation of the in-center hemodialysis treatment room on 04/23/2025 at 10:19 AM revealed a prepared Heparin syringe stored at patient treatment station #4 that was not labeled with the time prepared and initials of staff preparing the medication. Observation of the in-center hemodialysis medication preparation area on 04/23/2025 at 10:32 AM revealed eight prepared Heparin syringes stored in a drawer that were not labeled with the time prepared and initials of staff preparing the medication. Review of the facility “Policy: 1-06-01, Title: Medication Policy” last revised October 2023 revealed, in part: “Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. Policy: 20. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication.” In an interview on 04/23/2025 at 10:33 AM, S1FA confirmed staff must label medications not immediately administered with the time prepared and their initials when preparing the medication.”

“ACID CONC MIX SYS-EMPTY ALL/PREV CORROSION CFR(s): 494.40(a) 5.4.4.2 Acid concentrate mixing systems: empty completely/prevent corrosion Acid concentrate mixing tanks should be designed to allow the inside of the tank to be completely emptied and rinsed according to the manufacturer’s instructions when concentrate formulas are changed. Acid concentrate mixing tanks should be emptied completely before mixing another batch of concentrate. Because concentrate solutions are highly corrosive, mixing systems should be designed and maintained to prevent corrosion. This Standard is not met as evidenced by: 14442 Based on observation, policy review, and interview, the dialysis facility failed to ensure the acid concentrate mixing equipment was maintained in a clean state. This deficient practice was evidenced by the dry acid mixing system having a large build-up of dried white crystallized substances. Findings: Observation of the acid concentrate mixing area on 04/23/2025 at 10:09 AM revealed the Granuflo Dry Acid Unit for mixing dry acid had a large build-up of dried white crystallized substances on the top of the unit. Review of the facility “Procedure: 1-20-04A, Title: Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure” revealed, in part: “8. Clean the exterior of the Granuflo dry dissolution unit with a mild detergent after each batch of acid concentrate is mixed.” In an interview on 04/23/2025 at 10:11 AM, S1FA confirmed the Granuflo Dry Acid Unit had a large build-up of dry acid and was not clean.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 14442 Based on observation and interview, the dialysis facility failed to maintain a safe environment. This deficient practice was evidenced by failing to secure two oxygen tanks that were observed to be freestanding in the in-center hemodialysis isolation room. Findings: Observation of the in-center hemodialysis isolation room on 04/23/2025 at 10:23 AM revealed two freestanding oxygen tanks not secured. In an interview on 04/23/2025 at 10:24 AM, S1FA confirmed the oxygen tanks were not securely stored. S1FA confirmed oxygen tanks should be secured in an oxygen tank holder or rack.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 14442 Based on record review and interview, the dialysis facility failed to ensure the interdisciplinary team adjusted the patient’s plan of care when a patient was unable to achieve desired outcomes. This deficient practice was evidenced by failing to develop and implement specific plan of care changes for a patient (#2) with a history of missed and shortened treatments for 1 (#2) of 3 (#1-#3) sampled patients. Findings: Review of Patient #2’s “Plan of Care Progress” notes revealed, in part: “Psychosocial. Goal Created: Patient displays effective coping skills and verbalizes understanding and ability to follow treatment regimen for preferred modality. Patient has adequate resources to meet psychosocial needs.” Review of Patient #2’s medical record revealed Patient #2 designated unstable on 03/06/2025 due to psychosocial issues. Review of Patient #2’s medical record revealed a prescribed hemodialysis treatment time of 210 minutes. Review of Patient #2’s treatment records from 04/05/2025 through 04/22/2025 revealed the following: 04/05/2025 - treatment time 170 minutes, left AMA. 04/08/2025 - missed treatment. 04/10/2025 - treatment time 180 minutes, left AMA. 04/12/2025 - treatment time 185 minutes, left AMA. 04/15/2025 - missed treatment. 04/17/2025 - missed treatment. 04/19/2025 - treatment time 182 minutes, left AMA. 04/22/2025 - missed treatment. Review of Patient #2’s plan of care and medical record revealed no documented evidence of ongoing assessment of reason(s) for not adhering to ordered treatment time and no changes to plan of care. Patient #2’s care plan was not updated to reflect the patient’s current noncompliance with dialysis prescription. In an interview on 04/24/2025 at 11:48 AM, S2MCS confirmed that the interdisciplinary team did not update Patient #2’s plan of care to include noncompliance with treatments. S2MCS confirmed there was no evidence of recent changes or interventions to address missed and shortened treatments.”