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FTA Drug and Alcohol Regulation Updates |
Test Reporting Guidelines |
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Q & A Q Does my lab have to test for specimen validity or for adulterants?
A No, each employer should consult with their respective MROs to determine if/when validity tests should be performed and when additional tests for interfering substances/adulterants should be performed. The employer should then take the necessary steps to ensure their laboratory is willing and able to conduct the specified tests under these circumstances or obtain a new laboratory that is.
Q If the employer conducts FTA drug and alcohol tests and law enforcement officers conduct tests under their own authority, whose tests results take precedence? A The test results obtained by the employer shall take precedence for purposes of compliance with Parts 653 and 654.
The information presented on this page should be used to update Chapter 6 of the Implementation Guidelines. |
DHHS Provides Guidance for Test Result Reporting The DOT regulation (49 CFR Part 40) permits laboratories to conduct additional tests to determine the validity of a specimen. To ensure consistency among laboratories, the Department of Health and Human Services (DHHS) has established guidelines to standardize procedures, definitions, and reporting procedures. A laboratory may determine the nitrite concentration, creatinine concentration, specific gravity, and pH for the primary specimen following scientifically suitable methods that produce results that are accurately quantified. If the laboratory suspects the presence of an interfering substance/adulterant and the laboratory is unable to identify the interfering substance, the laboratory may send the specimen to another DHHS certified laboratory that has the capability of conducting the validity tests and identifying the interfering substance. When a laboratory reports the test result, they must report the result as either Negative, Positive, or Test Not Performed. For Positive and Negative tests they must also include an explanation on the Custody and Control Form (CCF) when the specimen is dilute. If the result is neither positive or negative, the “Test Not Performed” box must be checked and one of the following explanations must be provided on the “Remarks” line. (1) Fatal Flaw (e.g., broken seal), Specify (2) Uncorrected Fatal Flaw; Specify (3) Specimen Unsuitable; Cannot Obtain Valid Drug Test Result (4) Specimen Adulterated: Ž Nitrite too high Ž pH is too high or too low Ž Presence of adulterant detected, Specify (5) Specimen Substituted: Not consistent with normal human urine The quantitative results for validity tests (e.g., nitrite concentration, creatinine concentration, actual specific gravity, or actual pH) may not be routinely reported to the MRO, but may be provided to the MRO upon request on a case by case basis. The MRO must report the test result to the employer as Negative, Positive, Test Not Performed or Test Canceled. If a primary specimen is dilute, the MRO must also report to the employer that the next time the donor is selected for a drug test, the employer may require the specimen to be collected under direct observation. If the test on the primary specimen was not performed due to a fatal flaw or an uncorrected fatal flaw, the MRO must report the results as Test Not Performed and Test Canceled. Under this circumstance, the MRO reports to the employer that the test is canceled, the reason for the cancellation, and that no further action is required unless a negative test result is required. If the primary specimen is unsuitable and a valid drug test result cannot be obtained, the MRO should obtain additional information from the laboratory and contact the donor to inform him/her that the specimen was not suitable for testing or contained an unexplained interferrant. The MRO should inquire as to medications the donor may have taken. If an acceptable explanation is provided to the MRO, the MRO will report the test as canceled and provide the reason for the cancellation. If the explanation is not acceptable, the MRO should report the test as cancelled, provide the explanation for why the test was cancelled, and notify the employer that a second collection must be performed immediately under direct observation. If the primary specimen is adulterated or substituted, the MRO reports the test result as Adulterated or Substituted and Refusal to Test. The MRO reports to the employer that the donor refused the test and the donor’s right to have the split specimen tested is withdrawn. |