Ask X3What does 49 CFR 40.97 (What do laboratories report and how do they report it?) require?
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As a motor-carrier owner, here is what laboratories are required to report and how they must report it under 49 CFR 40.97:
* What to Report:
* The laboratory must always report the specimen type.
* For every primary specimen, the laboratory must report actual results falling into one of three categories (rather than just reporting the category name):
1. Negative results: Reported as "negative" or, for urine only, "negative-dilute" (including numerical values for creatinine and specific gravity).
2. Non-negative results: Reported with specific details as applicable (e.g., positive with drugs/metabolites and numerical values; adulterated with adulterants, confirmatory values, and remarks; positive-dilute urine with drugs, numerical values, creatinine, and specific gravity; substituted urine with confirmatory creatinine and specific gravity values; or invalid results with remarks, including specimen validity test numerical values for oral fluid or pH for urine).
3. Rejected for testing: Reported as "Rejected for Testing" with remarks.
* The laboratory must provide quantitative/numerical values for positive drug results, adulterated or substituted results, and negative-dilute urine results (creatinine and specific gravity) to the MRO, even without a request.
* How to Report:
* Directly to the MRO: Results must be sent directly and exclusively to the Medical Review Officer (MRO) at their place of business. Laboratories must *not* report results to or through the DER or a service agent like a C/TPA.
* Transmission Methods for Negative Results: Send a legible image or copy of the fully completed, signed Copy 1 of the CCF (via fax, courier, mail, or electronic transmission), or provide an electronic laboratory results report containing the mandatory minimum elements listed in the regulation.
* Transmission Methods for Non-Negative and Rejected Results: You must transmit a legible image or copy of the fully completed Copy 1 of the CCF signed by the certifying scientist (via fax, courier, mail, or electronic transmission), and you may additionally provide the electronic laboratory results report.
* Timing and Protection: Results must be transmitted in a timely manner (preferably the same day the certifying scientist finishes review), and both the laboratory and MRO must ensure the information is securely protected against unauthorized access or release during storage and transmission.