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)
V0111 IC-SANITARY ENVIRONMENT
CFR(s): 494.30

The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.


This STANDARD is not met as evidenced by:
Based on observations, facility policies and procedure, and interviews, it was determined the facility failed to ensure: 1. Staff followed the facility procedure for bleach preparation to prevent transmission of bloodborne pathogens. 2. Staff followed facility policy for antisepsis prior to cannulation of the dialysis access site in one of two observations for Access of AV (arteriovenous) Fistula or Graft for Initiation of Dialysis which included PI (Patient Identifier) # 13. This had the potential to negatively affect all patients who dialyze at this facility. Findings include: Facility Procedure: Mixing Bleach Published: 08/25/2020 Version: 4 Procedure ...2...measure amount of water into labeled opaque container...ensure proper concentration: 1:100 = 1- part bleach plus 99 parts water 1:10 =1- part bleach plus 9 parts water ...4. Label opaque container with "Bleach Solution", strength of solution, date and time prepared and your initials. 5. Cover opaque container with lid. 6. Discard solution daily at end of treatment... Facility Policy: Access Assessment and Cannulation Policy Number: 45178 Version 3 Published 7/5/22 Purpose: The purpose of this procedure is to provide guidance for ...placement of needles in an AV Fistula or AV Graft... Background: Before each treatment...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin... Skin Disinfection: 1. Disinfect cannulation sites as follows using any of the disinfectants below: 70% (percent) alcohol pad: Using gentle friction, clean the access site ...for 30 seconds and allow to dry before cannulating. 1. During observations of care on the in-center treatment room on 4/18/23, the surveyor observed the following: At 9:15 AM, the 1:100 bleach containers located across from station 12 and station 13 with solution present was uncovered and no date prepared was documented on the container. An interview was conducted on 4/18/23 at 9:15 AM during the observation with EI (Employee Identifier) # 14, CCHT (Certified Clinical Hemodialysis Technician) who confirmed the bleach was uncovered and no preparation date was documented on the bleach container. At 10:10 AM, the 1:100 bleach container located across from station 23 did not have the preparation date documented on the bleach container. At 10:40 AM, 11:00 AM, and 11:50 AM, the 1:100 bleach container located across from station's 12/13 remained uncovered. On 4/19/23 at 9:00 AM, the surveyor observed the 1:100 bleach container across from station's 18 and 13 were not covered. EI # 15, CCHT, present during the observation, reported there was no lid for the bleach container and confirmed the bleach container was not covered. On 4/19/23 at 9:03 AM, the bleach container located next to the TriStation was uncovered. An interview was conducted on 4/19/23 at 9:03 AM with EI # 15, CCHT, who was present at the TriStation during the observation confirmed the bleach container was uncovered. An interview was conducted on 4/20/23 at 10:50 AM with EI # 1, Director of Operations who confirmed staff failed to follow the facility bleach preparation procedure. 41624 2. During an observation of care on 4/18/23 at 10:17 AM at station 10, the surveyor observed EI # 16, CCHT, perform access site antisepsis to PI (Patient Identifier) # 13's AV Fistula or Graft site. EI # 16 utilized an alcohol prep pad to cleanse access site number one in a circular motion for five seconds, then immediately accessed the site with the needle. EI # 16 then utilized a second alcohol prep pad, cleansed access site number two in a circular motion for five seconds, then immediately accessed the site with a needle. EI # 16 failed to cleanse the access sites for 30 seconds and wait for the alcohol to dry per policy before accessing the sites with a needle. An interview was conducted on 4/20/23 at 10:40 AM with EI # 1 who confirmed EI # 16 did not perform antisepsis and cannulate the access sites per policy.