MRO of positive-only results from non-certified lab

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scricks

MRO of positive-only results from non-certified lab

Post by scricks » Wed Jun 30, 2010 3:35 pm

I am an MRO assistant. The physician in my office is a certified MRO. Recently we had a lab contact us and ask for our MRO services for positive-only tests. The lab is located inside a large medical center and is conducting pre-employment drug tests on its own prospective employees. This lab is not HHS certified, nor is it CAP-FUDT-certified. We could only find a basic pathology certification from CAP. The MRO is wary of working with a lab that does not seem to be certified to perform toxicology testing. Is the MRO allowed to certify results from a lab that is not certified? Any advice you could give would be greatly appreciated.



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Re: MRO of positive-only results from non-certified lab

Post by Robert Swotinsky MD » Thu Jul 01, 2010 9:04 am

These are nonregulated tests. (Correct!?). Thus, there are no laws about what the MRO is "allowed" to do.

Many MROs, including yours, are reluctant to review results that are not from laboratories that are certified as having met certain standards. In addition to wanting to see quality testing programs, MROs are wary of liability from handling potentially bad results. My experience has been that hospital laboratories often perform screen-only tests, i.e., tests that are not reliable. If this is the case, the MRO should encourage the employer to use a laboratory that only reports positive results after they have been confirmed positive, and should not agree to review the results unless/until confirmation testing is assured. Certified labs also assure a variety of other quality factors, such as staff qualifications, record security, acceptable performance on blind proficiency tests, etc. But, confirmation testing is at the top of the lists of things I'd insist on before getting involved.

scricks

Re: MRO of positive-only results from non-certified lab

Post by scricks » Thu Jul 01, 2010 10:08 am

Yes, these are non-regulated tests. The lab does use GC/MS as its confirmatory method. They did however, let us know that for amphetamines, they must send it out to a different lab for confirmation, which seems odd. Our MRO expressed concern because the hospital let us know that the MRO that was reviewing their tests when they were using an outside certified lab has refused to review the tests if they were doing the testing because they were not SAMHSA certified. This is the first time he has been asked to review tests by a non-certified lab, so we just want to make sure we cover all of our bases before we agree! Thank your for the input!

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