Update on DOT Drug & Alcohol Testing

Programs

FL DOE MeetingFebruary 2010

Dr. Donna SmithFirstLab, Inc.

dsmith@firstlab.com

All DOT Return to duty and follow-up drug tests must be conducted using direct observation specimen collection procedures After a prolonged court battle, the DOT

prevailed in implementing a Part 40 rule change that requires employers to conduct DOT RTD and FU drug tests under direct observation specimen collection procedures

Requirement became effective August 31, 2009 Direct observation procedures include the

requirement for donors to re-position clothing and be visually inspected by the observer to determine if they are wearing a specimen adulteration/substitution device

2009

DOT Return to Duty & Follow-up Tests

• DOT RTD/FU Tests are only conducted on safety-sensitive employees who have had a previous positive test, refusal to test or other violation of the DOT drug & alcohol regulations

• DOT RTD/FU tests are NOT used for:−Employees returning to safety-sensitive duty after

lay off, workers’ comp injury, or other absence−Drug tests conducted as part of a DOT driver

physical examination−Employees who have self-referred for substance

abuse treatment and are returning to work

2010

• Revisions to HHS Guidelines issued October 2008 with an effective date of May 1 2010. − Final revisions DO NOT include any authorization for “alternative”

specimens, POCT (instant or rapid tests), or testing for additional drug classes for federal drug testing programs

• The HHS Guidelines apply only to federal employees subject to testing under Executive Order 12564 and Public Law 100-71

• DOT issued a Notice of Proposed Rulemaking (NPRM) Feb 4, 2010 to apply the DHHS Guidelines revisions to DOT-mandated testing programs

− DOT’s NPRM essentially proposes to adopt most of the DHHS Guidelines revisions

− The comment period ends April 5, 2010

− Final rule will likely be issued in May 2010

2010 DHHS Changes

• Change in cut-off levels − Lower cut-off levels for cocaine and amphetamine testing

- Cocaine 150ng/mL screening; 100 ng/mL confirmation- Amphetamines 500ng/mL screening; 250ng/mL confirmation for methamp

& amp» Only require 100 ng/mL of accompanying amphetamine to report

methamphetamine positive

• Expected Impact of change− Slight increase ( <10%) in amphetamine and methamphetamine

confirmed positives− Confirmed amphetamine positives have been increasing in federal

drug testing for past 2-3 years- Large percentage (70+%) are being reported as MRO verified negatives

because of prescriptions for Aderall

− Will increase the window of detection for use; may counter somewhat the effect of specimen dilution

21010 DHHS Changes

• Adding testing for Ecstasy (MDMA).− Screening cut-off for MDMA is 500 ng/mL; confirmation for MDMA, MDA,

& MDEA at 250 ng/mL.

• Impact of Change− Confirmed positive tests for the designer amphetamine analogs.− % positive expected to be very low—Ecstasy “craze” is largely passé’

• Requirement to conduct 6 AM analysis on all screening tests for opiates− Currently 6 AM testing is only conducted when morphine screening

result is 2000 ng/mL or greater− Change will require screening analysis for 6AM at 10 ng/mL cut-off

• Impact of Change− Potentially more specimens reported positive for 6 AM− Some evidence to suggest that 6 AM is present in urine of recent heroin

users even when morphine concentrations are below 2000 ng/mL

2010 DHHS Changes

• DHHS certification of Instrumented Initial Testing Facilities (IITF). − IITFs authorized only for initial screening; any confirmation testing required

would be done at a DHHS certified drug testing laboratory.− IITFs will report negative results to MROs; will send presumptively

positive, adulterated or substituted specimens to certified laboratory for further testing

- Certified laboratory will conduct both screening and confirmation analysis on specimens received from IITFs

• Impact of change− Large laboratory systems, may use an IITF facility for all their

screening and retain only one or two laboratories for confirmation testing

- Potential for increased time for positive, adulterated, substituted results reporting—transfer of specimen, rescreening at laboratory, etc.

− “Unbundled” invoicing for laboratory analysis- One price for testing at IITF; additional price for testing at certified laboratory

2010 DHHS Changes

• Certified laboratories may now use LC/MS, LC/MS/MS, and GC/MS/MS for confirmation analyses in addition to the existing approved methodology GC/MS• Laboratories must validate all confirmation

methods/technologies used

• Impact of Change• For certain drug/drug metabolites, additional MS methods

may conserve specimen volume• May make confirmation faster and less complex for certain

target analytes by reducing specimen preparation steps

2010 DHHS Changes

• New Federal Custody and Control Form- Will include documentation for reporting results and

transferring specimens from an IITF- Includes “testing authority” designation in Step 1

– HHS, NRC, DOT (including DOT agency—FMCSA, PHMSA, etc.)

• Impact of Change- Collectors have to familiarize themselves with new

form- Accuracy of “testing authority” designation - Use of “old forms” after new form effective date- Collector and donor portions of the form are largely

unchanged

New Federal CCF

NO Changes on the Horizon

• Use of hair, saliva or POCT devices for federally-mandated testing

• Expansion of drug testing panel for federal testing to include opioids, benzodiazepines, etc.

• Use of blood alcohol testing when breath testing is not available or is not feasible

• Expansion of specimen validity testing requirements

• Expansion of definitions of “safety-sensitive”

National Data Base for CDL Holder Drug & Alcohol Violations

• Congressional funding authorization for FMCSA now includes a requirement for FMCSA to establish a national data base of drug and alcohol violations by CDL holders

• FMCSA has not issued proposed regulations to establish and implement the database.

• Employers, MROs and TPAs may have to report violations by CDL holders and employers will have to access database to check for violations when hiring a CDL employee