Lab Test Regulation

I am a Medical Technologist, or more commonly known as a lab rat. I worked hard for the title. Essentially, I did pre-med coursework as an undergraduate student, then put in more time in college to acquire the necessary skills and training to be able to take the tests to be able to call myself first a Medical Laboratory Technician, then a Medical Technologist. I did my clinical training at both Grady Hospital and at what was then Georgia Baptist Hospital (it became WellStar Atlanta before it closed in 2021). I will always be an MT. I worked from 1980-2005 in that field.

Along the way, I also learned to be a manager. Now the laboratory field does not train people to be management. You normally are thrust into the position by virtue of your skills and/or longevity in the job and suddenly your coworkers are now your subordinates, and all human relations hell ensues. I didn’t do that. I changed jobs and went into it. I knew what I wanted to do and I did it. It’s still a pain in the tookus, but not quite as bad that way.

One of the myriad characteristics of all laboratories is that they are highly regulated ‘beasts’. You practically cannot move without somebody wanting to regulate what you are doing. It varies as to who, how much, what they are looking for, and so forth, but somebody is up in your grill all the time. I got really good at the drill.

And it didn’t bother me. Why not you ask? Isn’t all that oversight just the government getting in your business? Well, yes, it is, BUT… it’s the purpose of that oversight that makes me good with it.

You see, regulations (which are just another name for laws put out by government departments) are meant to make sure that what any particular business does or does not do will NOT harm the consumer’s life, health, well-being, pursuit of a better life, or unnecessarily defraud them in any way. I’m good with that. The government is not going to stand in your way if you just want to go stand in your front yard and burn up everything you own just for the heck of it. But they WILL try to make sure that the air fryer you got for Christmas meets standards, so it doesn’t short out while you are sleeping and burn the house down while you and your family are sleeping. That’s regulation.

In spite of what the rockheads in Congress, our General Assembly, on FOX, and elsewhere have to say about “government interference” (meaning regulation), I am very much in favor of the FDA establishing some guidelines for some of these “lab test” that people are getting via 23&Me, Ancestry, and whoever else. Why? Quite frankly, none of these labs are regulated so who the heck knows if there is a smidgen of quality control being done, what kind of standards are being used, or even the proficiency of the people performing the testing. DNA testing is notorious for being finicky and easily contaminated. How are they handling the procedures? What are their accessioning protocols? Confirmations? And so on.

There are other tests as well. This is just one area that needs to be addressed. It just happens to fall in my wheelhouse. Veterinary tests are out there as well. Probably some in Agriculture that are more “chemical”, but still in the laboratory realm. Environmental testing could fall in here as well. Regulation is NOT a bad thing. Done correctly, it saves lives and protects the consumer.

Does this affect Georgians? Yes, it does although it may be only a few people. It could be just a few people who want a test for a very rare DNA mutation that is very seldom seen, but it might have cropped up in their family and they are terrified of a pregnancy that may carry it. It is tests like these that the FDA is considering. I get the concern on both sides. The stakes are so high.

Have questions? Please let me know. It is things like this and more that I want to be able to either answer or find the answers for you. It matters.