Medical question about California Business Code logic.

[groman]

I was browsing online to see what kind of at-home testing kits are available (You can get anything from viruses, to mitochondrial DNA, to drugs, etc.) Most of the these are actually just sample collection kits and the test is done in a lab by mail. However, I noticed that a lot of the sites selling these have a disclaimer specifically for California, and as it turns out, California requires some sort of a medical referral for any medical lab work done. I was curious so I looked up the cited section of the California Business Code 1240-1246.5 . The crucial part is this:

The tests that may be conducted pursuant to this section are:
pregnancy, glucose level, cholesterol, occult blood, and any other
test for which there is a test for a particular analyte approved by
the federal Food and Drug Administration for sale to the public
without a prescription in the form of an over-the-counter test kit.
** A test approved only as an over-the-counter collection device may not
be conducted pursuant to this section.**

So, not pursuant to that section means general rules apply – need a referral from a doctor (or a reasonable substitute for one). Well, it’s a law. In fact, some human being somewhere wrote the sentence

A test approved only as an over-the-counter collection device may not
be conducted pursuant to this section.

I understand that laws don’t necessarily have to make sense. Often you can track mystical laws and exemptions to powerful lobby groups. However, I am drawing a blank on this one. I just can’t, for the life of me, figure out how somebody came up with this distinction. Only simple tests can be done at home – there isn’t yet a test strip or cheaply built device for everything. However, the complexity of the test has nothing to do with the health aspects of it. Simple at-home tests can theoretically take a long time (although most seem to be relatively instant) and reveal problems that needed immediate medical attention long time ago. Complex mail-away tests can be mailed overnight and have turn around just as fast as a routine lab work at your doctor’s office.

If the idea was to force people to consult a doctor if they have medical questions or suspect a condition, then what differentiates home mail-in testing from home test-strip testing? Both can be used to diagnose (and probably more often than not, misdiagnose) very serious conditions. Why is it that I am allowed to wake up one day and decide “I want to find out my blood sugar level” but I need a doctor to write me a note if I wake up one day and decide “I want to find out my 24-hr saliva DHEA levels”

Is there some aspect of the law I am just not seeing or am I correct in understanding the intent of that sentence is making home test kits exempt, as long as you do them yourself. If you pay a professional lab to do it, you need a referral.

Thanks,

Groman

Disclaimer: I am not asking medical or legal advice. I am not actually interested in getting a home test kit, nor selling them, nor advising anybody else to buy or sell one. I just happen to enjoy both legal and medical geekiness and I get very excited when these things intersect.

[henrijohns]

I’m guessing privacy concerns. If you suspect your roommate of having a disease, you could send in a blood sample from his shaving towel without his knowledge. (Although you could probably get a prescription and substitute his sample anyway.)

[groman]

@henrijohns

I’m guessing privacy concerns. If you suspect your roommate of having a disease, you could send in a blood sample from his shaving towel without his knowledge. (Although you could probably get a prescription and substitute his sample anyway.)

Right, but I think disease tests fall under a different category. Those are typically anonymous, since the sample you mail in only has a number on it. I am fairly sure those are sold OTC here in California and you don’t need a doctor’s note. In fact, other than the post mark, it’s not clear how they would know you’re from California anyway.