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Family Care Specialists in Colorado banned from COVID-19 vaccine program for mishandling and storage issues

Colorado Dept. of Public Health and Environment
Colorado Dept. of Public Health and Environment(CDPHE)
Published: May. 25, 2022 at 1:03 PM MDT|Updated: May. 25, 2022 at 1:25 PM MDT
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PUEBLO, Colo. (KKTV) - A Pueblo-based business has been banned from taking part in the COVID-19 vaccine program.

The Colorado Department of Public Health and Environment announced on Wednesday that they terminated Family Care Specialists from Centers for Disease Control and Prevention’s COVID-19 Vaccination and the Vaccines for Children (VFC) program. The termination came as the state identified “compliance issues” when it comes to the storage and handling of the vaccines.

During an inspection, CDPHE observed the following violations:

-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.

Thirteen people are recommended to vaccinate. Those patients should have received instructions on how to handle the process, according to CDPHE.

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

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