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IS YOUR CLIA SHINGLE HANGING ON THE WALL?

10/30/2008

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If not, why not?  Are you ashamed that you analyze urine or saliva?  Do you think there is something wrong with analyzing such?  Are you really unaware that tens of thousands of “labs” perform simple urine tests for everything from employment drug screening, to a wrestling coach evaluating whether a high schooler has dehydrated himself to meet a weight limit, or even pregnancy verification?  Do you really think you have to use your RBTI instruments in a dark corner where no one can see?

Human urine (and saliva) testing is here and it is here to stay.   Whether the method employs dipsticks, instruments, reagents, a simple visual check, or whatever, our society can hardly function without the feedback information needed to better understand a subject’s who, what, where, when, and how.

It appears that the US government long ago grew tired of flaky results from flaky “labs” being submitted in conjunction with Medicare or Medicaid claims.  The Department of Health and Human Services developed a program to register laboratories so as to create some order.  The program allows responsible labs to obtain a CLIA (Clinical Laboratory Improvement Amendment) certificate to hang on the wall to show they are in compliance.  The certificate looks good hanging up there.  It inspires confidence in your clients that you know what you are doing.

Does the process require you to state that you think the Reams Biological Theory of Ionization is scientifically proved and validated?  Of course not.  That is silly.  RBTI is merely a particular way of evaluating test results, not a special way of testing.   The application form for your CLIA does not ask you what 1.5 brix means, it asks only whether or not you use a refractometer to test human urine.  The form does not try to pry into your brain to determine what you think a 6.4 pH means, it only asks if you perform a pH test.

A side effect of the registration process is that you will need to thoroughly understand how to deal with specimen cups, leftover specimens, and contaminated instruments, pipettes, etc.  Like it or not, we live in a germ-wary world and approved sanitizing or disposal techniques are a must.   Bio-hazards are not tolerated.

If you are in the business of RBTI, you may want to think about whether a US Health and Human Services CLIA certificate would look good hanging up there next to those fancy certificates showing where or from whom you received your RBTI training and analysis techniques.  Does HHS need to know beforehand whether you want a certificate because you will be handling Medicare or Medicaid claims?  That is certainly doubtful, but whether you ever do submit such claims, or not, you must pay any fees associated with the certificate.

And can you imagine the sudden doubt that may come into the mind of someone out to disrupt your business when they look on the wall and realize that you are properly registered with the US government as a lab?  If you were a tough guy on a crusade would you really want to explain to a judge why you decided to bother a peaceful RBTI consultant with a certificate like this on the wall?

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    Rex Harrill

    Long time RBTI fan.  Mainly I seem to be a librarian these days.

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