I have a pair of big, round prescription eyeglasses that cover at least half of my face, and until recently, I wore those glasses regularly, confident in the knowledge that they suited me just fine. About a month ago, however, my family and I were spending a nice evening together, watching television, surfing the ’net, and sharing gentle barbs with one another, when my younger son said, “Mom, the ’70s called, and they want their glasses back!”
I was reminded of my son’s statement as contributing writer Renee DiIulio and I discussed regulatory issues affecting the clinical lab for Renee’s Industry Overview (see page 24). According to sources interviewed, one of the major problems with current clinical lab regulations is that some of them are stuck in the 1970s. Confusion ensues when we try to adhere to outdated requirements while dealing with current technology. But updating regulations is an extremely slow process. One source quoted a colleague who said, “Glaciers are swift by comparison.”
This is not to say that regulations don’t do what they’re designed to do. There is ample evidence to demonstrate that quality deficiencies in clinical labs have decreased significantly in the past decade. However, there is always room for improvement.
Many believe the solution lies in developing performance-based standards. “We need to rethink our regulatory philosophy so we can manufacture instruments and verify their performance based on a performance-based standard,” according to Ronald H. Laessig, PhD, professor of population health sciences and professor of pathology and laboratory and medicine at the University of Wisconsin.
In the meantime, until all clinical lab regulations make their way out of the ’70s, labs have no choice but to do everything they can to comply while using all resources available to them, including regulatory agencies and manufacturers. It’s a headache for the already overworked lab professional; lab managers have told me that deciphering regulations is, by far, the most frustrating part of their jobs. However, they are hoping that speaking out about the need for clear, standardized, updated regulations will make a difference. One can only hope.
PS: I still have my big, round glasses plucked from the ’70s—I just don’t venture out of the house with them on anymore!
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