The state health department is going to start doing onsite inspections of COVID-19 vaccine providers as well as a host of other precautionary measures as Colorado continues its efforts to get all eligible residents vaccinated. The decision comes on the heels of the state confiscating vaccines and opening an investigation into the Dr. Moma Health and Wellness Clinic in Colorado Springs.
“We are going to begin doing onsite inspections of providers to ensure that they have the appropriate equipment on site that they have the temperature logging and ensure that they are adhering to the practices and principles that they attested that they would,” said Scott Bookman, the state health department’s COVID-19 incident commander, during a press conference Thursday.
Online, the state provides information on vaccine provider enrollment, which indicates “CDPHE will conduct compliance site visits, informal observations, or investigations, in conjunction with local public health agencies, as necessary.”
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Providers are also required to have approved refrigeration storage, a licensed provider and agree to the state’s conditions to provide vaccines.
Other measures the Colorado Department of Public Health and Environment and Joint Vaccine Task Force say they are taking to ensure providers are meeting storage and handling requirements include:
- Reaching out to all enrolled COVID-19 vaccine providers to verify temperature monitoring devices and offer them approved, certified digital data loggers, if needed.
- Requiring temperature logs be submitted for all enrolled COVID-19 vaccine providers that have received vaccines in the last 30 days.
- Implementing compliance site visits for enrolled COVID-19 vaccine providers to assess adherence to program requirements and recommendations. Specifically, site visits will:
- Identify and address areas where providers are doing well and areas needing additional follow-up.
- Identify and address educational needs of COVID-19 vaccination providers to help them meet program requirements.
- Ensure vaccine recipients are receiving properly managed and viable vaccines.
- Ensure that vaccines are distributed according to jurisdictional priorities and ensure equity in the distribution. For providers seeking to become an enrolled COVID-19 vaccine provider, CDPHE will start requiring providers to submit 5 days of temperature logs with their enrollment packet prior to approval to ensure their vaccine storage units are capable of correctly storing vaccines.
When asked if the Dr. Moma clinic was inspected before it started vaccinating Coloradans, Bookman said he didn’t have that information. Bookman said the health department uses social media, county health department inspections and complaints to determine if a vaccine provider needs to be inspected.
“This is an active investigation, and we're still trying to understand everything that led up to this moment. We're obviously onboarding a huge amount of providers to partner with us to meet the task of this mass vaccine campaign,” Bookman said during the press conference. “It is the responsibility of the provider to adhere to all of the guidelines that are set forth to make sure that they have the equipment onsite that they said that they had onsite, and that it's in working order.”
Last week, the state health department confiscated about 3,000 doses from the Dr. Moma clinic after El Paso County health officials observed problems in vaccine storage, handling, preparation, mass clinic operations and poor record-keeping practices, according to a press release from the state.
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More than 1,000 vaccination appointments at the clinic were canceled last weekend in addition to another 6,000 appointments scheduled through May 8, the state health department said.
On Tuesday, all 3,933 patients who received a dose of a COVID-19 vaccine at the clinic were instructed to get re-vaccinated at a different vaccination site in the state. For patients who received their first dose of either the Moderna or Pfizer vaccine, they need to get two more doses. For those who were fully vaccinated, they were instructed to get one additional dose of the vaccine they already received.
Due to a lack of clinical data, it’s not recommended that people get more than three doses of the COVID-19 vaccine, according to the Centers for Disease Control and Prevention.
“We have administered millions of doses of the COVID vaccine in Colorado at this point and this is an incredibly isolated incident,” Bookman said. “It is disappointing. It is concerning. Our heart goes out to those who received a vaccine at this clinic.”
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