PUEBLO, Co. — The Colorado Department of Public Health and Environment (CDPHE) terminated Family Care Specialists from participation in Centers for Disease Control and Prevention’s (CDC) COVID-19 Vaccination and the Vaccines for Children (VFC) programs for violating standard health practices.

CDPHE identified compliance issues when the staff conducted a routine, scheduled COVID-19 and VFC storage and handling exam at Family Care Specialists.

During this routine inspection, CDPHE staff observed the following violations of the VFC and CDC COVID-19 Vaccination programs.

  • Failure to report key staff changes to the VFC or COVID-19 Vaccination programs in a timely manner.
  • Failure to meet staff training requirements for storage and handling, preparation, and administration of VFC and COVID-19 vaccines. 
  • Failure to monitor storage unit temperatures at all times and failure to use equipment and practices that comply with the CDC Storage and Handling Toolkit.
  • Failure to submit COVID-19 vaccination data to the Colorado Immunization Information System (CIIS) within the 72-hour timeframe required by the CDC COVID-19 Vaccination Program Provider Agreement.
  • Failure to properly dispose of expired COVID-19 vaccine. 
  • Failure to properly store and monitor COVID-19 vaccine upon receipt. 
  • Failure to report VFC and COVID-19 vaccine temperature excursions to the manufacturer and CDPHE. Temperature excursions are required to be reported to CDPHE immediately per CDPHE’s VFC and COVID-19 Temperature Excursion Policies. Vaccines exposed to out-of-range temperatures may have reduced potency which may impact the viability of the vaccine. 
  • Failure to submit the required site visit documentation and resolve outstanding compliance issues by the April 2, 2022 deadline and subsequent deadline extensions of April 27, 2022 and May 9, 2022.  

CDPHE determined that 13 people are recommended for revaccination due to improper storage and handling of vaccines. These individuals received a total of 20 doses, five of which were COVID-19 vaccines. Other vaccines that failed to meet proper storage requirements include hepatitis A, hepatitis B, haemophilus influenzae type B, measles-mumps-rubella-varicella (MMRV), pneumococcal, diphtheria-tetanus-acellular pertussis, polio, and varicella. 

Those vaccinated by Family Care Specialists can contact CDPHE at cdphe_vacs@state.co.us or 303-692-2700.

If patients witness what they believe to be unsafe or unethical vaccination practices, CDPHE encourages them to file a complaint using our online complaint form. Anyone with knowledge or concerns about an enrolled COVID-19 vaccine provider can file a complaint.