What’s the problem with the original CLIA QC regulations?
Have you ever wondered why it has taken ten years to issue the CLIA Final Rule? Did CMS take those years to do further research into quality and the best practices for laboratory QC? NO, that’s not the answer. What we saw was a series of postponements, delay after delay, while the government tried to figure out how to appease the various interests or stakeholders, as they’re now called. • Manufacturers wanted the regulations to be as business-friendly as possible. They didn’t want additional burdens of proof or support placed on them, such as the need to document the effectiveness of their QC instructions, which was required in the original CLIA rules. They opposed that provision and won that battle. Whether the government was in the hands of the Democrats or Republicans, it has been kinder, gentler, friendlier, and more subject to business interests and lobbying. • Even though the intent of CLIA was to be sure that all laboratories provide quality services, the regulations were merely
