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)
V0130 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:
Based on observation, review of facility policy, and interview, it was determined the facility failed to ensure all equipment used in the isolation room was designated and labeled for "isolation" only. This had the potential to affect all Hepatitis B susceptible patients and staff at the facility. Findings include: Facility Policy: Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+) Published 3/20/13 Policy Number: None Version: Seven Purpose: To prevent transmission of Hepatitis B Equipment and Supplies: Separated dedicated supplies and equipment...must be used to provide care to the HBsAG positive patient: All supplies used in the isolation room/area such as clamps, blood pressure cuffs, testing reagents, etc., should be labeled "isolation" and not routinely removed. 1. On 4/18/23 at 12:25 PM an observation of the facility isolation room was conducted which included inspection of the equipment/supplies housed in the isolation unit. There was no isolation label on the following equipment/supplies: Patient treatment chair One hemodialysis machine # (number) 4 Two containers for 1 to 100 bleach concentration One gallon size container of Pure Bright ultra bleach One Rolling Sharps container One Rolling Bio-hazard can Two Treatment stools One Spectra Last centrifuge One small refrigerator One 60 milliliter (ml) bottle of Myron L pH-ORP (potential hydrogen-oxidation reduction potential) sensor storage solution One 60 ml bottle of Mesa Labs 10.0 pH standard buffer solution One 60 ml bottle of Mesa Labs 14.0 mS/Cm (milli Siemens per centimeter) conductivity solution One 32 ounce bottle of Myron L 442-300 TDS (total dissolved solids)/Conductivity standard solution One two shelf stainless steel cart storing various supplies, including dialyzers, fistula needles, barriers, tape, needles, gloves, syringes, and tubing. An interview was conducted on 4/20/23 at 10:40 AM with Employee Identifier # 1, Director of Operations who confirmed all equipment and supplies in the isolation room were not labeled and designated for isolation only use.