Dialysis Clinic, Inc.

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 48995 Based on review of facility policies, procedures, and checklists, observations, and staff interviews, the facility failed to identify and remove expired emergency medications/supplies from the Emergency Code cart (where emergency medications and supplies are stored) and the Emergency Preparedness tub (a kit containing emergency evacuation medications/supplies, including site dressings, saline, IV tubing, available to accommodate evacuated hemodialysis patients). This failed practice had the potential to expose all 46 patients on census to expired supplies/medications during an emergency. Findings are: A. Review of the policy and procedure titled Expiration Dates of Meds and Supplies, dated 12/2010, revealed expiration dates will be either the manufacturer’s expiration date or the number of days after opening, whichever is first. B. Observation of the facility Emergency Code cart, on 1/3/24 at 3:10 PM, revealed the following expired medications/supplies: 1. 6- 1 milligram (mg)/milliliter (mL) Epinephrine (a medication used to restore cardiac rhythm during a cardiac emergency) injectable vials with an expiration date of 12/2023. 2. 1- 1 mg/10 mL Epinephrine injectable vial with an expiration date of 1/1/24. 3. 3- 20 mL syringes (unopened) with an expiration date of 5/12/23. C. Review of the facility checklist, titled Monthly Emergency Code Cart Checklist, revealed the checklist failed to include the 20 mL disposable syringes, and the 1 mg/mL and 1 mg/10 mL Epinephrine injectable vials for expiration date review. D. During staff interview on 1/3/24 at 3:30 PM, the Director of Nursing (DON) confirmed the medications/supplies listed above, for the Emergency Code cart, were outdated and in need of replacement and confirmed the Emergency Code cart checklist did not include all supplies and medications requiring review for expiration dates. E. Observation of the facility Emergency Preparedness tub, on 1/8/24 at 8:25 AM, revealed the following expired supplies: 1. 1- unopened box of nitrile exam gloves with an expiration date of 9/25/23. 2. 1- unopened box of nitrile exam gloves with an expiration date of 3/15/23. 3. 1- unopened box of nitrile exam gloves with an expiration date of 5/17/23. F. Review of the facility checklist, titled Monthly Emergency Preparedness Tub Supply List, revealed the checklist failed to include the nitrile exam gloves for expiration date review. G. During staff interview on 1/8/24 at 02:20 PM, the DON confirmed the supplies listed above, located in the Emergency Preparedness tub, were outdated and in need of replacement and confirmed the Monthly Emergency Preparedness Tub Supply List failed to include the nitrile exam gloves for expiration date review.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 48995 Based on review of facility policies and procedures, record review, and staff interviews, the facility failed to document the provision of Central Venous Catheter (CVC-an indwelling device surgically placed into a large vein most commonly the internal jugular, subclavian, or femoral for venous access for the provision of hemodialysis) care and dressing changes for 1 of 2 patients (Patient 9) with a CVC. Total patient sample was 5 and facility census was 46. This failed practice provided the opportunity to expose Patient 9’s bloodstream to infectious pathogens. Findings are: A. Review of the facility policy and procedure titled Hemodialysis (HD) Vascular Access Catheter Disinfection, Exit Site Care, and Dressing Change, dated 11/2023, revealed CVC access site care and dressing changes are to be to be performed and documented in the patient’s HD record by a nurse at every HD treatment. B. Review of Patient 9’s HD record, on 1/4/24 at 9:30 AM, revealed no documentation of the patient’s CVC care and dressing changes for HD treatments dated 12/15/23 and 12/24/23. C. During staff interview on 1/4/24 at 4:00 PM, the Director of Nursing (DON) confirmed Patient 9’s HD records dated 12/15/23 and 12/24/23, did not contain documentation for the provision of CVC care and dressing changes.”

“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: 47269 Based on review of facility policies and procedures, observations, and staff interviews, the facility failed to identify and remove expired Hemastix reagent (HR) strips (testing strips, used to assess for potential blood leaks in hemodialysis (HD) machines when the HD machine blood leak alarm sounds). Expired HR strips have the potential for reduced blood detection sensitivity. This failed practice of utilizing expired HR strips had the potential to expose all 46 patients on census to undetected blood leaks during HD treatments. Findings are: A. Review of the facility policy and procedure titled Management of a Blood Leak Utilizing Hemastix Reagent Strip, dated 12/2019, revealed HR strips are to be used to assess if a blood leak is suspected when the HD machine blood leak alarm sounds. The facility policy and procedure failed to ensure expired HR test strips were not available for use, or used, by staff. B. Observation of the patient HD treatment area on 1/3/24 at 3:45 PM, revealed a bottle of HR strips with an expiration date of 2/28/23. C. During staff interview on 1/3/24 at 3:45 PM, the Director of Nursing (DON) confirmed the HR strips located in the patient HD treatment area were expired and confirmed the HR strips are used by staff to assess for potential blood leaks in HD machines when the HD machine blood leak alarm sounds.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 47269 Based on review of facility policies and procedures, observations, and staff interviews, the facility failed to post the telephone complaint numbers for the End Stage Renal Disease (ESRD) Network (an external organization with which dialysis patients may file grievances and complaints anonymously) and the state survey agency with the Patient’s Rights and Responsibilities poster. This failed practice had the potential to prevent all 46 patients on census from filing an anonymous complaint with the ESRD Network or the state survey agency. Findings are: A. Review of the facility policies and procedures titled Patient Rights & Responsibilities - Complaints and Grievances related to Health Care, Discrimination and Privacy, dated 10/1/22, and Dialysis Clinic Inc. (DCI) Patient Rights and Responsibilities, Rules and Regulations, dated 1/2021, revealed patients have the right to be informed of external grievance mechanisms and processes including how to contact the ESRD Network and the state survey agency. B. Observation of the facility’s patient lobby, on 1/3/24 at 9:00 AM, revealed the Patient Rights and Responsibilities poster did not include the ESRD Network or the state survey agency telephone complaint number. C. During staff interview on 1/3/24 at 4:15 PM, the Director of Nursing (DON) confirmed the Patient Rights and Responsibilities poster failed to include the telephone complaint numbers for the ESRD Network and the state survey agency.”