University of Louisville Dialysis Center, LLC

“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: 35949 Based on observation, interview, and facility policy review, it was determined the facility failed to dedicate and label all equipment and supplies used to care for dialysis patients positive for bloodborne pathogens in one (1) of 1 isolation rooms. Failure to dedicate and label equipment and supplies used when treating dialysis patients requiring bloodborne pathogen isolation had the potential to provide a mode for cross-contamination and the potential spread of bloodborne pathogens and negatively impact the well-being of the seventy-one (71) patients receiving dialysis treatments at this facility. Findings include: A review of a facility policy titled “G43 Hepatitis B: Control & Management,” revised on 07/21/2022, revealed, “31. The Hepatitis B isolation room or area must have a sink with water for handwashing and must have a dedicated dialysis machine, equipment, instruments, supplies and medications that will not be used by Hepatitis B susceptible patients. Disposable supplies/equipment, such as disposable thermometers, should be used whenever possible. A separate restroom for patients with Hepatitis B may be present if required by current state and/or local regulations.” Further review of the policy revealed, “34. All supplies, including durable ones, will be clearly labeled as “isolation”, [sic] for use in the Hepatitis B isolation room or area only, and will not be removed for use in other areas without disinfection per the applicable procedure.” An observation of the isolation room and interview with the Interim Clinic Manager on 12/04/2023 at 12:10 PM revealed the following unlabeled and undedicated items: two (2) boxes of gloves, one (1) waste basket, 1 dialysis chair, and 1 oxygen tank and carrier. The Interim Clinic Manager confirmed the items in the isolation room were unlabeled and undedicated. The Interim Clinic Manager stated all items should be labeled and dedicated for use only in the isolation room so as not to allow removal from the isolation room and prevent the spread of bloodborne pathogens. During an interview on 12/08/2023 at 12:10 PM, the Clinical Regulatory Manager stated, “any items in the isolation room” need to be marked and “nothing should be in there that isn’t marked.” The Clinical Regulatory Manager stated the process when establishing an isolation room is to “label anything and everything that moves.” She stated the unit staff are trained and educated to “label everything” and “not to take anything from that room.””

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 35949 Based on observation, interview, and facility policy review, it was determined the facility failed to protect patient records from unauthorized access in one (1) of 1 unrestricted storage areas. Failure to restrict access and protect patient records had the potential for unauthorized access and use of protected health information (PHI) of the 71 patients receiving dialysis treatments at this facility. Findings include: A review of a facility policy titled “G32 Medical Records,” revised on 03/24/2023, revealed, “Purpose: To ensure that [facility name] medical records: provide accurate, complete and consistent patient care data, facilitate patient care, are readily available and systematically organized to facilitate compilation and retrieval of information, are maintained according to the most stringent guidelines [facility name] Policy (sic), HIPAA [Health Insurance Portability and Accountability Act] requirements and/or federal/state regulations, and serve as a legal and financial record.” Observation on 12/04/2023 at 9:45 AM of a storage area located in an unlocked room with the Interim Clinic Manager and Clinical Regulatory Manager revealed thirty-four (34) cardboard boxes. Five (5) of the 34 boxes were labeled “Patient.” The Clinical Regulatory Manager opened one of the boxes labeled “Patient” and stated the box contained “patient information.” The Interim Clinical Manager stated that the janitorial staff arrived at the unit “after hours and after we’ve left.” The Interim Clinical Manager stated the medical records should have restricted access due to containing PHI; she was unaware records were stored in this area. Both the Interim Clinic Manager and the Clinical Regulatory Manager observed the door leading from the hallway into the storage area and confirmed the door had no locking mechanism and allowed unrestricted access by the janitorial staff into the area where the patients’ records were stored.”