rules

CDC Broke Their Own Rules: Spread Contamination

The CDC was responsible for a weeks long delay in delivering Covid-19 test kits. By breaking their own rules, they accidentally contaminated the tests, making them completely useless. Reporters have been asking pointed questions about the delay but the government never came up with a good explanation for why a crucial test, desperately needed to stop the Covid-19 spread wasn’t hitting the streets as promised. They finally admitted, they blew it.

Why have rules if nobody follows them?

According to a spokesperson with the Food and Drug Administration on Saturday, the Centers for Disease Control and Prevention broke their own rules. Because of the breach of protocol, contamination made the test results utterly worthless, slowing the pandemic response by weeks.

The CDC “made its test in one of its laboratories” which is not “consistent with its own protocol.” Instead, the test kits should have come from the agency’s manufacturing facilities. Americans are getting more than a little frustrated at asking over and over again, “why do we have rules if nobody ever follows them?”

Valentine’s day came and went without the CDC coming up with an answer about when the tests would be ready. They couldn’t even be sure if it was a manufacturing mistake or a more serious design flaw.

Contamination in manufacturing

After an official with the FDA dropped in to the Atlanta labs on February 22, it was determined that they broke the rules. “Contamination was most likely occurring during the manufacturing process and that the CDC had appeared to have violated its own manufacturing protocols.” It took until the tail end of February to fix the problem.

By February 27, “the FDA and the CDC worked together to remanufacture the CDC test with the help of IDT, an outside manufacturer” an administration official confirms. IDT knows how to follow the rules. “The remanufactured tests functioned correctly and were shipped to public health labs.”

Before they got the kits working as expected, the CDC allowed the health labs to skip the third phase of the test which had been giving them the problems. Once they finally figured out it was a manufacturing problem, rather than design, the experts cut some red tape to “facilitate the production and quality control processing of test kits made by one of its contract manufacturers.”

“The test manufactured by IDT was distributed and has encountered no issues, thus supporting the conclusion that it was a manufacturing issue” the FDA admitted in a written statement. According to the CDC, “the matter is being investigated by the Department of Health and Human Services.”

No relaxation until there’s a test

America still doesn’t have the testing capacity we require. States are considering relaxing some of the restrictions but they can’t be sure it’s safe until there are enough tests to show that the spread is contained. “Routine quality control measures aim to identify these types of issues. Those measures were not sufficient in this circumstance, and CDC implemented enhanced quality control to address the issue and will be assessing this issue moving forward.”

The next step will be to turn the matter over to the inspector general for HHS. That person is expected to investigate and issue a report in a year or so. As with most inspector general reports, it will likely find government wrongdoing and issue a stern warning not to get caught doing it again.

You Might Like
popup close button