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)
V0126 IC-HBV-VACCINATE PTS/STAFF
CFR(s): 494.30(a)(1)(i)

Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B.


This STANDARD is not met as evidenced by:
Based on review of medical records (MR), facility policy, and interview, it was determined the facility failed to ensure all susceptible patients were vaccinated or a declination form was obtained per policy. This affected one of one new patient, including Patient Identifier (PI) # 1, and had the potential to negatively affect all patients served by the facility. Findings include: Facility Policy: Patient Guidance for Hepatitis B Vaccination Policy Number: 47676 Published 2/7/22 Version 5 Purpose: Provide guidance for hepatitis B vaccination Hepatitis B Vaccine Guidelines: The Hepatitis B vaccine (HBV) shall be offered to all susceptible patients... ...Patients shall sign a vaccination consent/declination form. ...A protective antibody response is 10 or more multigenerational units per milliliter... Declination: ...Each offering of the vaccine should be documented in the patient's medical record. 1. PI # 1 was admitted to the facility on 3/4/23 with a diagnosis of End Stage Renal Disease. Review of the laboratory (lab) results collected 3/7/23 revealed documentation of an Anti-HBs of below 10 (not immune-susceptible to hepatitis b virus). Review of the MR printed on 4/19/23 revealed no documentation PI # 1 was offered the HBV vaccination per the facility policy. An interview was conducted on 4/20/23 at 9:40 AM with Employee Identifier # 1, Director of Operations, who confirmed there was no documentation PI # 1 was offered the HBV vaccination.