Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391

Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 012515 (X3) Date Survey Completed 04/20/2023
Name of Provider or Supplier Fresenius Medical Care Opelika Street Address, City, State 2609 Village Professional Drive, Suite 2, Opelika, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
V0122 IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
CFR(s): 494.30(a)(4)(ii)

[The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.


This STANDARD is not met as evidenced by:
Based on observations, facility policy and procedure, and interview, it was determined the facility failed to ensure: 1. Staff cleaned and disinfected the dialysis station after patient treatments. This affected two of two observations of the cleaning and disinfection of dialysis station. 2. Staff cleaned one of one blood spots at a dialysis station in the isolation unit. This affected Patient Identifier (PI) # 20, one of one patients dialyzing in the isolation unit, and had the potential to negatively affect all patients susceptible to hepatitis B virus, visitors and staff. Findings include: Facility Policy: Cleaning and Disinfection of the Dialysis Station Reference Number: 47806 Published: 11/07/2022 Version: 13 Purpose The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. Responsibility All dialysis facility staff Background The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent contamination, a dialysis station must be cleaned and disinfected between dialysis patients... Definition Dialysis Station: Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment... Equipment in the dialysis station may include... the following: Dialysis machine/cycler and attachments such as IV (Intravenous) pole, B/P (Blood Pressure) cuff... Chair/bed...Individual television and remote, dialysis wall box. General Cleaning The dialysis station could become contaminated with blood and other body fluids during treatment. Work Surface Cleaning and Disinfection without Visible Blood using Bleach Solutions. All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glistening wet and let air dry unless otherwise specified by the manufacturer. Procedure Follow the steps below to disinfect the dialysis station after each dialysis treatment: Step: ...3. Use a cloth wetted with 1:100 bleach solution... to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV pole, B/P cuff... wall behind chair... 4. Clean all surfaces. Make the surfaces glisteningly wet and allow to air dry... 5. ...While wiping, remember to wipe all surfaces of the machine including the air detector chamber, blood pump casing... and wherever the extracorporeal circuit was in contact with the machine. Work Surface Cleaning and Disinfection with Visible Blood less than ten milliliters and Other Potentially Infectious Material using Bleach solutions: Use 1:100 bleach solution to clean surfaces with visible blood. After cleaning up all visible blood, use a new cloth with 1:100 bleach solution for a second cleaning of the surface.... Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible. 1. An observation was conducted on 4/18/23 at 9:40 AM to observe Employee Identifier (EI) # 16, Certified Clinical Hemodialysis Technician (CCHT) perform cleaning and disinfection of station 7. EI # 16 failed to clean and disinfect the hanson connectors, the blood pump casing, and the undersides of both patient treatment chair trays. An interview was conducted on 4/20/23 at 10:40 AM with EI # 1, Director of Operations (DO), who confirmed staff failed to follow the facility policy and procedure for dialysis station cleaning/disinfection. 2. An observation was conducted on 4/18/23 at 9:55 AM to observe EI # 14, CCHT perform cleaning and disinfection of station 18. EI # 14 failed to clean and disinfect the television, television arm, and the counter behind the station. An interview was conducted on 4/20/23 at 10:40 AM with EI # 1 who confirmed staff failed to follow the facility policy and procedure for dialysis station cleaning/disinfection. 3. During observation of the isolation room on Tuesday, 4/18/23 at 12:25 PM, a large (slightly larger than size of quarter) spot of blood was observed on the floor underneath the treatment chair. Review of the facility daily patient schedule revealed the isolation room was utilized on Monday, Wednesday and Friday's for isolation patient PI # 20. The facility staff failed to immediately clean the blood spill and disinfect the isolation station per policy. An interview was conducted on 4/20/23 at 10:40 AM with EI # 1, who confirmed staff failed to follow the facility policy and procedure to immediately clean the blood spill and disinfect the isolation station. 30952