January 28, 2020 | NEWS | By April Kwan
On Jan. 15, Colorado Attorney General Phil Weiser and the Colorado Department of Public Health & Environment (CDPHE) finalized the order to shut down 11 COVID-19 testing sites.
They cited certification violations and failure to obey COVID-19 reporting laws. In addition, one of the COVID-19 testing sites lacks certification from Clinical Laboratory Improvement Amendments (CLIA), which is necessary to perform lab analyses on humans. These COVID-19 testing sites are located across Colorado, spanning Boulder, Denver, and Colorado Springs.
Along with other remarks, Weiser tweeted that, “our consumer protection section also has received a significant number of complaints about safety conditions at their testing sites, including concerns about the appropriate use of personal protective equipment.”
These 11 testing sites are operated by two companies: The Center for COVID Control and Macagain Corp. Two of these locations, operated by Macagain Corp, are located in Colorado Springs at 3629 Betty Dr. and 2910 Wood Ave.
According to the CDPHE and Weiser, Macagain Corp. did not report COVID-19 test results as required. When questioned, Macagain’s co-owner, Catherine Silver, mentioned technology was at fault and shared that COVID-19 test result data was not being deliberately withheld.
As for the Center for COVID Control, they were presented with two cease-and-desist notices. Failure to observe these notifications may cause the CDPHE to seek legal action to prevent the continuation of unlawful COVID-19 testing.
The first cease-and-desist notice states that, “The Colorado Department of Public Health and the Environment (CDPHE) has requested each site’s CLIA certificate and has determined that each site is not appropriately certified. You have therefore failed to obtain all necessary governmental licenses required to perform the tests that your sites offer to Colorado consumers.”
The second notice states that, “entities testing in Colorado are required to submit test results through CDPHE’s electronic laboratory reporting platform or through other CDPHE-approved methods. Results shall include patient information, provider information, test result information, and any other information deemed necessary by CDPHE.”
The notices also asked for the Center for COVID Control to adhere to six requirements before restarting test administration.
The following must be reported/adhered to:
- Report the amount of administered rapid tests and PCR samples to be tested in Colorado.
- Report information from the PCR testing which includes identification, testing organization, contact information, and Clinical Laboratory Improvement Amendments (CLIA) identification number.
- Adhere to the fulfillment of PHO 20-33 in each reported test.
- Report the amount of samples collected for PCR testing that have yet to be sent out for examination in Colorado.
- Adhere to the fulfillment of PHO 20-33 in each test awaiting to be sent out for PCR testing.
- Report on the internal reporting policies and procedures on rapid and PCR testing.
More information on the situation can be accessed via the official press release from Phil Weiser.