In science, the need for quality systems is everywhere. Every institution, including the Centers for Disease Control and Prevention, the premier public health agency in the US, can produce seriously flawed tests and results when the pillars of a quality system are absent.
This New York Times article from April describes some fascinating and troubling quality problems at the CDC labs that developed the first covid-19 test kits.
Calling the CDC’s lab practices “sloppy,” officials from the FDA outlined lapses in sound laboratory and production practices:
- A basic separation of functions was missing, leading to contamination and unreliable results.
- There was a lack of expertise in commercial manufacturing.
- No one was in charge of the entire process.
It was public health laboratories (the CDC’s “customers”), that alerted the CDC to these problems almost immediately. The CDC failed to detect the unreliable tests on their own before distributing the kits.
A commercial producer took over production and these issues then went away.
FDA regulations provide a framework for getting the right systems into place. For example, the Good Laboratory Practice regulations clearly outline separation of functions, designation of roles (management, study director, quality assurance unit, etc.).
This story of failure, beyond the delays to epidemiologists and grieving families, highlights the need for quality systems, not a reliance on individual heroes.
Even the most highly trained and resourced scientists will suffer quality lapses if they do not follow certain procedures and practices. If they find themselves operating with a flawed system, they may realize they were set up to fail.
It was the FDA, a regulator highly competent in inspection of quality systems and testing, that cited these gaps during an inspection.
A larger investigation into the CDC’s response to the coronavirus is pending. This may be the tip of the iceberg. I shared this article to once again demonstrate the need for the quality function in labs of even the highest levels of specialization and expertise.
About the photo: I hiked up Mt Defiance on Friday. It was difficult but not grueling. Next time I will visit Warren Lake on the way down for a swim. The view is of Mt Hood. You could see as far as John Day from the summit.