Published on April 13, 2015 and effective April 13, 2015, the Department of Transportation (DOT) approved the use of electronic CCFs for DOT-mandated drug and alcohol testing programs.

To ensure that the DOT regulations conform to SAMHSA's approved chain of custody and control procedures, the DOT is issuing this final rule to expand the current definition of the CCF in 49 CFR 40.3 to include all versions of the CCF as approved by OMB. They are amending §40.45 to explain that the 5-part form can be a paper form or an approved electronic form, as long as the employer ensures that security and confidentiality concerns are addressed. The DOT is amending §40.73 to require entities using an eCCF to follow the eCCF procedures approved by SAMHSA through the NLCP inspection process.

While approved for use, it is important to note that an eCCF is not usable until the laboratory has gone through the approval process for the eCCF. Currently there are no laboratories with eCCF approval, however, DSI Medical will keep its customers informed as approvals are issued.

The eCCF requires the same collection of information and distribution of information to the relevant parties as the paper CCF requires. With the approved eCCF, HHS is not requiring collection of any new or different information. The only change from the paper CCF to the eCCF is the mechanism for collecting and transmitting the requisite information. Before implementing an eCCF, HHS-certified laboratories must provide a detailed plan and proposed standard operating procedures (SOPs) for SAMHSA to review and approve through SAMHSA's National Laboratory Certification Program (NLCP). The review of validation records, specimen records, SOPs, staff training records, and practices associated with the eCCF will be part of the NLCP inspection process. Once the eCCF is approved for use through the NLCP inspection process, it may be used in the DOT drug testing program, as well as the Federal Workplace Drug Testing Program. For more information regarding this approval process, please contact the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Division of Workplace Programs, National Laboratory Certification Program at (919) 541-7242, or via email at nlcp@rti.org.

It is important to note that electronic signatures are not otherwise acceptable in Part 40. The use of the eCCF will create an exception so that electronic signatures will be acceptable on these forms only and not throughout the rest of Part 40.

Please feel free to contact your DSI Medical Representative with any questions regarding eCCF.

For complete notice:

http://www.gpo.gov/fdsys/pkg/FR-2015-04-13/pdf/2015-08256.pdf