Split sample testing

Scope

These regulations apply to drivers of commercial motor vehicles (CMVs) subject to drug testing under the Federal Motor Carrier Safety Regulations (FMCSRs).

Regulatory citations

• 49 CFR 40, Subpart H — Split specimen tests

Key definitions

• Medical review officer (MRO): A licensed physician who is responsible for receiving and reviewing laboratory results generated by an employer’s drug testing program and evaluating medical explanations for certain drug results.

• Split specimen: The part of the specimen that is sent to a first laboratory and retained unopened, and which is transported to a second laboratory in the event that the driver requests that it be tested following a verified positive test of the primary specimen or a verified adulterated or substituted test result.

• Split specimen collection: A collection in which the specimen collected is divided into two separate specimen bottles, the primary specimen and the split specimen.

Summary of requirements

The driver has 72 hours from the time of notification (of a positive and/or refusal to test because of adulteration or substitution test result) to request the test of the split specimen. The request may be verbal or in writing.

If the driver does not request a test of the split specimen within 72 hours, the driver may present to the MRO information documenting that serious injury, illness, lack of actual notice of a verified test result, inability to contact the MRO, or other unavoidable circumstances prevented the driver from making a timely request.

If the MRO concludes that the driver has a legitimate reason for failing to contact the MRO within 72 hours, the MRO must direct that the test of the split specimen take place, as if the request was timely.

When the driver makes a timely request for a test of the split specimen, the MRO must immediately provide written notice to the laboratory that tested the primary specimen, directing the laboratory to forward the split specimen to a second certified laboratory.

The MRO must also document the date and time of the driver’s request.

If the driver has made a timely request for a test of the split specimen, the employer must ensure that the test takes place.

Drivers are not required to pay for the test from their own funds before the test takes place, but the employer may seek reimbursement for the cost of the test. The regulations take no position on who ultimately pays the cost of the test, so long as the employer ensures that the testing is conducted as required and the results are released appropriately.

Laboratory actions. When the laboratory testing the primary specimen receives written notice from the MRO to send the split specimen, the following items must be sent to the second laboratory:

• The split specimen in its original bottle with the seal intact;
• A copy of the MRO’s written request; and
• The copy of the custody and control form (CCF) that identifies the drug(s)/metabolite(s) or the validity criteria to be tested for.

The information forwarded to the second laboratory must not identify the driver.

The laboratory testing the split specimen must test it for the drug(s)/metabolite(s) detected in the primary specimen.

The procedures that must be followed, based on the result of the testing of the split specimen are as follows:

The MRO must inform the Office of Drug and Alcohol Policy and Compliance (ODAPC) of the failure to reconfirm.

Failure to reconfirm scenarios and actions:

• A urine specimen split failed to reconfirm because the substitution criteria were not met and the split specimen creatinine concentration was equal to or greater than 2mg/dL but less than or equal to 5mg/dL, the MRO must direct the DER to ensure the immediate collection of another specimen from the driver under direct observation, with no notice given to the driver of this collection requirement until immediately before the collection.
• The split failed to reconfirm and the primary specimen’s result was also invalid, the MRO must direct the DER to ensure the immediate collection of another specimen from the driver under direct observation, with no notice given to the driver of this collection requirement until immediately before the collection.
• The laboratory failed to reconfirm all of the primary specimen results and the split was reported as invalid, the MRO must report to the DER and the driver that the test must be canceled and the reason for the cancellation. The MRO must direct the DER to ensure the immediate collection of another specimen from the driver under direct observation, with no notice given to the driver of this collection requirement until immediately before the collection. The MRO must inform the ODAPC of the failure to reconfirm.
• The laboratory failed to reconfirm any of the primary specimen results, and the split was reported as adulterated and/or substituted, the MRO must contact and inform the driver that the laboratory has determined that the split specimen is adulterated and/or substituted. The MRO must follow the procedures of 40.145 to determine if there is a legitimate medical explanation for the laboratory finding of adulteration and/or substitution.
  • If the MRO determines that there is a legitimate medical explanation for the adulterated and/or substituted test result, the MRO must report to the DER and the driver that the test must be canceled and inform ODAPC of the failure to reconfirm.
  • If the MRO determines that there is not a legitimate medical explanation for the adulterated and/or substituted test result, the MRO must report the test to the DER and driver as a verified refusal to test. The MRO must inform drivers that they have has 72 hours to request a test of the primary specimen to determine if the adulterant found in the split specimen is also present in the primary specimen and/or to determine if the primary specimen meets appropriate substitution criteria.
  • Except when the request is for a test of the primary specimen and is being made to the laboratory that tested the primary specimen, the MRO must follow the procedures of 40.153, 40.171, 40.173, 40.179, 40.181, and 40.185, as appropriate.
  • The laboratory that tests the primary specimen to reconfirm the presence of the adulterant found in the split specimen and/or to determine that the primary specimen meets appropriate substitution criteria must report the result to the MRO. If the test of the primary specimen reconfirms the adulteration and/or substitution finding of the split specimen, the MRO must report the result as a refusal to test. If the test of the primary specimen fails to reconfirm the adulteration and/or substitution finding of the split specimen, the MRO must cancel the test.
• The laboratory failed to reconfirm one or more but not all of the primary specimen results and split specimen was invalid, adulterated and/or substituted.  In the case where the laboratory reconfirmed one or more of the primary specimen result(s), the MRO must follow procedures for reconfirmed positive, adulterated, or substituted test result(s) and report that the split was also reported as being invalid, adulterated, and/or substituted. The MRO must inform the DER to take action only on the reconfirmed result(s).
• The split specimen was not available for testing or there was no split laboratory available to test the specimen. The MRO must report to the DER and the driver that the test must be canceled and the reason for the cancellation. The MRO must direct the DER to ensure the immediate recollection of another specimen from the driver under direct observation, with no notice given to the driver of this collection requirement until immediately before the collection. The MRO must notify ODAPC of the failure to reconfirm.
• The laboratory failed to reconfirm result: specimen not available for testing. If the specimen is not available for testing, the MRO must report to the DER and the driver that both tests must be canceled and the reason for cancellation. The MRO must direct the DER to ensure the immediate collection of another specimen from the driver under direct observation. No notice of this collection may be given to the driver until immediately before the collection.