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 012500 (X3) Date Survey Completed 09/16/2021
Name of Provider or Supplier Fmc Capitol City Street Address, City, State 255 South Jackson Street, Montgomery, 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, Hepatitis B Summary, and interview, it was determined the facility failed to ensure all patients were offered the hepatitis B vaccine series. This affected 1 of 1 new patient reviews, Patient Identifier (PI) # 1 and had the potential to negatively affect all patients served by the facility. Findings include: Policy: Patient Testing and Vaccination for Hepatitis B Published: 08/20/2014 Version: 4 Hepatitis B (HB) Vaccine Guidelines: The Hepatitis B vaccine shall be offered to all susceptible patients... Patients shall sign a vaccination consent/declination form... A protective antibody response is 10 or more milliinternational units (mIU) per milliliter (anti-HBs > (greater than) 10mIU/mL). Hepatitis B Vaccine: Recombivax: Dialysis dependent for patients aged 20 or older = (equal) 40 ug (microgram) in 1.0 ml (milliliter) at 0, 1, and 6 months. Hepatitis B Vaccine: Engerix-B: Dialysis dependent for patients aged 20 or older = 40 ug in 2 - 1 .0 mls at 0, 1, 2 and 6 months. Documentation in the patient's electronic MR system for administration as well as NON administrations is extremely important. These include: Refusals Allergic Vaccinated elsewhere... 1. PI # 1 was admitted to the facility on 3/15/18 with a primary diagnosis of End Stage Renal Disease. Review of the Hepatitis B Summary Report printed 9/14/21 revealed a hepatitis B surface antibody of < (less than) 10 on 7/29/21, susceptible. MR review on 9/15/21 revealed no patient consent, no vaccination record, and no declination/refusal for the Hepatitis B vaccination series, which was 53 days after admission to the facility. During an interview on 9/16/21 at 9:42 AM Employee Identifier # 1, Clinic Manager, confirmed staff failed to follow the facility policy for Hepatitis B vaccination.