Davita Hastings Dialysis Center

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 48995 Based on review of facility policies and procedures, observations, and staff interviews, the facility failed to maintain intact surface integrity of walls, floors, and equipment in the Water Room (a dedicated, secure room housing the facility water treatment system that has been fitted to provide source water, drains, and electric power needed to support the dialysis system) and Dialysate (a mixture of source water and chemicals used to clean hemodialysis (HD) patient’s blood during dialysis) Preparation Room. This failed practice did not allow for effective cleaning and disinfecting of the walls, floors, and equipment, which had the potential to expose all 30 in-center HD patients on census to microbial pathogens. Findings are: A. Review of the facility policy and procedure titled Physical Environment, dated April 2018, revealed the building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public. B. During observation of the facility environment with the Charge Nurse (CN) on 3/4/24 at 11:15 AM, the following areas were identified and confirmed in need of repair, cleaning, and/or replacement: Water Room 1. The painted walls presented with gouges, chipped paint, and stains throughout. 2. The pipes were coated in a greenish residue throughout. 3. The electrical outlet adjacent to the acid mixing tank was covered in a rust-colored residue. 4. The metal floor drain covers presented with flaking and peeling paint throughout. 5. The floor presented with dirt and debris throughout. Dialysate Preparation Room 1. The utility cart located on the north wall presented with chipped paint and rust colored residue throughout. 2. The built in shelves located on the east wall presented with dirt and debris with rust colored residue to the metal supports throughout. 3. The floor presented with dirt and debris throughout. C. During staff interview on 3/7/24 at 9:45 AM, the Interim Facility Administrator (FA) confirmed the facility failed to maintain intact surface integrity of walls, floors, and equipment in the Water Room and Dialysate Preparation Room. The Interim FA also confirmed the areas identified were in need of repair, cleaning, and/or replacement.”

“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: 48995 Based on review of facility policies and procedures, observations, and staff interviews, the facility failed to maintain the Reverse Osmosis (RO) machine (the primary method for purifying water for Hemodialysis (HD) treatments) in the Water Room (a dedicated, secure room housing the facility water treatment system that has been fitted to provide source water, drains, and electric power needed to support the dialysis system) to prevent leaks and corrosion of the RO outer metal covering. The facility also failed to maintain the B. Braun HD machines to prevent corrosion of the shelf which holds Peracetic acid (an organic peroxide based, colorless liquid with a low pH, used for disinfecting the HD machines) bottles, located on the back of the HD machines. This was found on all 14 HD machines in the facility, (12 located on the treatment floor and 2 in the Bio Med Room). This failed practice prevented the clean, safe, and functional working condition of the equipment. This had the potential to affect the facilities ability to provide uninterrupted HD treatments to all 30 in-center HD patients on census. Findings are: A. Review of the facility policy and procedure titled Physical Environment, dated April 2018, revealed the facility will implement and maintain a program to verify that all equipment is maintained and operated in accordance with manufactures recommendations. B. Observation of the facility Water Room, on 3/4/24 at 11:15 AM, revealed the RO machine had clear liquid draining from the back left bottom corner, into a nearby drain, and the RO’s bottom right metal panel had rust colored debris and corrosion noted. C. Observation of the B. Braun HD machines, on 3/6/24 at 9:00 AM, revealed the shelf, which holds the Peracetic acid bottles were located on the back of the HD machine, had rust colored areas throughout the shelf. D. During staff interview, on 3/5/24 at 9:30 AM, the facility BioMed Technician (BMT), confirmed the RO machine had been leaking for a couple of months, due to a problem with the membrane housing of the RO system and that the facility leadership was in discussions to either repair or replace the faulty part. The facility BMT further confirmed the prescence of rust-colored debris and the corrosion of the right bottom area of the RO machine, which needs repair and/or replacement. E. During staff interview, on 3/7/24 at 9:45 AM, the Interim Facility Administrator (FA), confirmed the the RO machine and the 14 HD machine shelves were in need of repairs and/or cleaning and confirmed the clean, safe, and functional working condition of the RO machine and the B. Braun HD machines is the responsibility of the Bio Med department and staff.”

“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: 47269 Based on review of facility policies and procedures, observation, and staff interviews, the facility failed to secure the room where 17 boxes of patient medical records were stored prior to shipment to an offsite storage facility. This failed practice had the potential to affect the privacy and confidentiality of past and current dialysis patients by not safeguarding patient medical records against unauthorized use. Census was 42 (30 in-center hemodialysis patients and 12 home peritoneal dialysis patients). A. Review of the facility policy and procedure titled Medical Records Custodian (MRC) and Maintenance, dated 10/2019, revealed the MRC is responsible for safeguarding the privacy and confidentiality of patient medical records against unauthorized use. B. During observation of the open, unsecured east office with the facility Administrative Assistant (AA), on 3/4/24 at 3:00 PM, 17 boxes labeled Iron Mountain were identified. C. During staff interview on 3/4/24 at 3:15 PM, the facility AA explained the 17 boxes labeled Iron Mountain contained past and current dialysis patient records designated for shipment to an offsite storage facility and the facility AA had not locked the east office as they were uncertain which facility key locked the door. The facility AA confirmed they are the designated facility MRC. D. During staff interview, on 3/4/24 at 4:30 PM, the Interim Facility Administrator (FA) confirmed it is the expectation of the MRC to safeguard the privacy and confidentiality of patient medical records against unauthorized use. The Interim FA further confirmed it is the expectation that patient medical records are stored in a secured room accessible to the MRC and the Interim FA only.”