The Department of Transportation (DOT) has reported that it will be making regulation changes in an effort to reduce the adulteration of urine specimens. The regulations that were first announced this summer will take full effect on November 1, 2008. If your company is mandated to comply with DOT regulations, it is essential that you familiarize yourself with the following information.
BACKGROUND
What did the DOT announcement say?
The report can be broken down into two major categories. The first part has to do with mandatory changes in the way some collections are performed. The second piece has to do with how the specimens are screened, reported and reviewed by the laboratory and the MRO. We have summarized the employer-specific contents of document for you here:
The Department of Transportation is amending certain provisions of its drug and alcohol testing procedures to change instructions for collectors, laboratories, medical review officers, and employers regarding adulterated, substituted, diluted, and invalid urine specimen results.
- It will become mandatory for laboratories to test all DOT specimens for specimen validity (i.e., adulterants and urine substitutes) and for laboratories to follow all Department of Health and Human Resources (HHS) protocols for doing so.
- Observed collections will afford slightly less privacy in order to guard against employee use of items designed specifically to beat the testing process.
- Directly observed collections will continue to occur only when there is reason to believe that an employee may attempt, or have reason, to evade the testing process.
- Items such as prosthetic devices designed to carry clean urine will be checked for by observers with both male and female donors. The observer will have the employee raise and lower clothing, and then put it back into place for the observed collection.
- Observed collections will now be required, rather than optional, for all return-to-duty and follow-up drug testing.
- In an effort to thwart the manufacturers of products designed to adulterate specimens, tables and charts outlining the adulterants and cutoff levels will no longer be published.
Where can I review the official DOT document?
At this link.
Whom does this ruling affect?
Employers, MROs, laboratories and collection sites who do DOT-mandated urine drug testing.
I do not do DOT urine drug testing or collections, does this topic affect me?
No. It does not.
As an employer who does DOT Urine drug testing, what must I do to remain compliant with the new specimen validity testing requirements?
Aside from familiarizing yourself with the changes outlined in this document, you do not need to do or change anything. Most certified laboratories will be changing processes to ensure that your laboratory testing panel continues to remain compliant with all rules and regulations.
When does the rule take effect?
All CFR Part 40 rules went into effect in August except for the directly observed requirements for return to duty and follow-up testing. This piece, and thus the entire CFR Part 40 ruling, takes effect on November 1, 2008.
Why did they make these changes?
The DOT’s revisions to its urine specimen collection and testing guidelines were put in place to improve the collection and screening process and help ensure that the goals of your testing program are not compromised.
SPECIMEN COLLECTION
What action must an employer take after receiving an invalid test result?
Following an invalid test result, employers should notify TOX Testing Services that this is a second collection and that it should be observed.
What does it mean to ‘observe’ a urine collection?
Observed collections are in place to ensure that donors are not using artificial means to submit their urine sample. To counteract this, when performing an observed collection, the collector must ask the donor to raise their clothing above waist and to lower their clothing below waist to ensure that there is not a prosthetic device.
When must an observed collection be performed?
In addition to the previously mentioned reasons that require the performance of an observed collection (e.g. following an invalid test result or a negative-dilute with a creatinine between 2 and 5 mg/dL), collections must be observed for all return to duty tests and for all follow-up tests.
I have a donor that requires an observed collection for a follow-up or return to duty test. Whom should I call?
Employers are required to ensure that certain collections are directly observed. TOX Testing Services is an FDA registered, CLIA accredited collection company trained to perform direct observations.
LABORATORY PROCESSES
Will TOX Testing Services change its prices for processing drug screens?
Specimen testing will remain compliant with the new DOT requirements at no additional cost to you.
What adulterants will TOX Testing Services screen for?
In addition to tests for pH, creatinine and specific gravity (when the creatinine is less than 20 mg/dL), all DOT specimens will now be tested for oxidizing adulterants.
Will the screening include oxidizing adulterant identification?
This new testing process does not include oxidizing adulterant identification - in the event of abnormal oxidant activity on the screen and confirmation, the specimen will be reported as invalid not adulterated.
What is specimen validity testing, and are all laboratories required to conduct it?
Specimen validity testing is the measurement of several substances and parameters to determine if the specimen submitted for testing is adulterated, diluted or substituted; and whether or not it is thus suitable for completing testing and obtaining a valid drug test result. Four tests make up the required validity testing: pH, creatinine, specific gravity (when indicated), and oxidizing adulterants. All laboratories are required to comply with this Federal mandate. There is an additional cost to the laboratory for running these tests, however TOX Testing Services has elected not to pass these fees along to our customers.
REPORTING
Will the way that laboratory results are reported to the Medical Review Officer change?
With this change in specimen validity testing, all test results will now include results for oxidizing adulterants. Also, whenever the laboratory reports a specimen as invalid due to an abnormal pH, the laboratory will automatically report the pH value, relieving the MRO of the burden of having to contact the laboratory to determine if the pH is low or high.
What changes are required for laboratory statistical reports?
The semi-annual laboratory statistical report sent to employers will not change. However, laboratories are now directed to provide an aggregate statistical summary report to the DOT for all DOT testing performed. This new report does not contain employer or mode-specific data.
[Source: Quest Diagnostics]
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