Substance Abuse Management

1. Substance Abuse Management Regulatory Updates Tuesday March 31, 2009 Distance Learning Session

2. Welcome • Diana Byrnes, Substance Abuse Management Specialist • Center for Urban Transportation Research (CUTR) • Project Manager for the FDOT Substance Abuse Management Oversight and Technical Assistance Program • Transportation Safety Institute Associate Staff Instructor • Certified Substance Abuse Program Administrator (C-SAPA)

3. Distance Learning - Things to Remember • We can hear you too • Cell Phones • Other Conversations • Typing • Hold

4. Course Goal • To inform you of the drug and alcohol testing regulation amendments that went into effect on August 25, 2008 • To educate you in key areas of potential non-compliance within your testing program

5. Poll 1 Participant Level of Experience

6. Basics of Drug and Alcohol Testing • Regulations: • 49 CFR Part 655 Federal Transit Administration: Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations • 49 CFR Part 40 US DOT Procedures for Transportation Workplace Drug and Alcohol Testing Programs

7. What does Part 655 tell us? • Defines Covered Employers • Defines Covered Employees • Defines the circumstances in which testing must occur (such as random rate, post accident criteria) • Establishes regulations concerning policy and training requirements • Defines the consequences for positive results and refusals to test (removal from s-s duty) • Conditions financial assistance to compliance (per OTETA)

8. What does Part 40 tell us? • The required procedures for the collection, analysis, MRO review, and reporting of drug and alcohol specimens • Safeguards the integrity of the program by establishing specific procedures for each step of the process • Must be consistent with US Department of Health and Human Services guidelines for federal workplace drug testing

9. Basics of Drug and Alcohol Testing • Test Types • Pre-employment(urine drug required, breath alcohol allowed) • Random(minimum rate is 25% urine drug 10% breath alcohol) • Post Accident(must always do both drug and alcohol!) • Reasonable Suspicion(urine drug or breath alcohol-depends on nature of suspicion) • Return to Duty(follow SAP instructions for test types) • Follow Up(follow SAP instructions for test type and frequency)

10. Basics of Drug Testing • DOT urine drug testing panel includes these five prohibited substances: • Amphetamines • Cocaine • Marijuana • Opiates • PCP • DOT panel can only include these five • Hair and blood are not acceptable DOT specimens

11. Basics of Urine Collection • Collectors must meet training qualifications in accordance with 40.33 • A Federal CCF must be used for all DOT collections • DOT urine collections must be “split” • Privacy enclosure must be free of potential contaminating agents, water sources and “hiding spots” • Bluing agent must be present in toilet water • Collection site must be secure (restricted access)

12. Basics of Laboratory • Labs must be certified by DHHS (Department of Health and Human Services) • A list is of certified labs is updated every month and published in the Federal Register during the first week of each month.

13. What happens at the Lab ? • Accessioning of specimen • Inspect condition of specimen • Review CCF for fatal or correctable flaws • Initial screening by immunoassay, includes specimen validity testing • Negative results report out • Non-negative results move on for further testing

14. Lab results reported to MRO • Negative Dilute with creatinine level between 5 and 20 ng/ml • Negative Dilute with creatinine level between 2 and 5 ng/ml • Positive or Positive Dilute • Adulterated • Substituted • Invalid

15. The Role of the MRO • MRO is the gatekeeper • Impartial, independent; protects the integrity of the testing process • Inspects MRO and Lab copies of CCF for errors • Obtains lab report inclusive of quantitative data • Interviews donor via telephone or in person • Recites Medical Miranda to donor • Verifies possible medical explanations • Has the authority to order additional testing, cancel a test, or deem a test to be invalid • Has the final word! Drug test results cannot be changed by anyone other than the MRO

16. Results from MRO Negative- no further action required, employee may begin or resume s-s duty Negative Dilute- follow policy regarding retesting, follow MRO instruction to recollect under direct observation (when creatinine in the 2-5 range) Positive with drug listed- remove employee immediately from s-s duty, follow policy Positive Dilute- POSITIVE, see above Cancelled- must be considered neither positive nor negative (follow MRO instruction, recollect under direct observation, second collection or no further action) Refusal to Test because of Adulterated or Substituted- remove employee from s-s duty, follow policy

17. Regulatory Updates Effective August 25, 2008

18. Video SpikeTV: Manswers

19. Available Products GOOGLEResults 1 - 10 of about 1,040,000 for beat a drugtest. (0.18 seconds) 

20. Prosthetic Devices

21. Amendments- Background • Overall purpose: • To make DOT required drug testing harder to “beat”. • To require specimen validity testing at all DHHS certified laboratories • To enhance the direct observation procedures • The manufacturing of adulterants, urine substitutes and prosthetic devices have made this necessary

22. Breakdown of Amendments to Part 40 Specimen Validity Testing Required-40.89 • What it means: Laboratories must test specimens for adulterants and substitutions using DHHS guidelines • Who does it effect:Labs • What you need to do: Update your policy to reflect this change (FL DOT Model Policy includes this is Section 16)

23. Breakdown of Amendments to Part 40 Direct Observation Procedures Change • What it means: Whenever there is a specific reason to believe a donor is attempting to tamper with or evade a test, a recollection under direct observation must take place • Who does it effect: Donors and Collectors • What you need to do: Make policy changes (FL DOT Model Policy includes this in Section 15)

24. Breakdown of Amendments to Part 40 Three new behaviors that constitute a Refusal to Test • What does this mean:additional measures taken tosecure the process from those attempting to evade or tamper with tests Who does this effect: Donors, collectors, employers • What you need to do: YouMUST include all of the behaviors in your policy (FL DOT Model Policy lists them in Section 14)

25. Breakdown of Amendments to Part 40 MRO can use a medical evaluation to determine prohibited drug use following an invalid result • What it means: When a (-) result is required and only an invalid result can be produced via urine, this provides a means to obtaining a negative result • Who it effects: Donors who produce invalid results, MROs, Employers • What do you need to do: Add this language to your policy (FL DOT Model addresses this inSection 20)

26. Breakdown of Amendments to Part 40 Negative Dilute Retesting • What it means:When a negative dilute result with a creatinine level between 5ng/ml and 20 ng/ml is reported; you are authorized to conduct a second collection. The second collection may not be directly observed and is the final result. • Who it effects:Donors, Employers • What do you need to do:Add this language to your policy, implement consistently (reference FL DOT Model Section 17)

27. Additional Information Regarding Negative Dilute Results Negative Dilute Results with a creatinine level between 2 and 5 ng/ml require retest under direct observation • What it means:Specimen that the human body can rarely produce • Who does it effect:Donors, collectors, Employers • What do you need to do:Check results carefully, when levels are not indicated, contact MRO. Always follow MRO instructions on how to proceed

28. Breakdown of Amendments to Part 40 No Split Testing of Invalid results • What it means:Donors will not be able to request that their B bottle (split specimen) be tested at another lab when the A bottle produced an invalid result • Who it effects: Donors with invalid results • What you need to do: add statement to policy (reference FL DOT Model Policy Section 21)

29. Breakdown of Amendments to Part 40 Stop Publication of Lab Methods • What it means: laboratory testing and analysis methods will no longer be published • Who it effects: The multi-million dollar industry that manufactures products designed to “beat” DOT drug tests! • What you need to do: Nothing

30. Breakdown Lab Reports to DOT • What does it mean: drug testing laboratories must report to DOT semi-annual statistical summaries on all of their DOT testing • Who does it effect: Labs and DOT • What do you need to do: Nothing

31. Poll 2 Zero Tolerance vs 2nd Chance

32. Return to Duty and Follow Up Tests At this time there is an Administrative Stay on making these test types mandatory direct observation collections • What does this mean:Employer Option still remains to conduct these tests under direct observation • Who does this effect:Second Chance Employers • What do you need to do:Determine if your agency would like to exercise the option; add it to your policy; apply it consistently (FDOT Model Policy for Second Chance Agencies exercises this option)

33. This concludes the Amendments

34. Anticipated Problem No D.O.C.’s @ P.S.C.’s • What it means:LabCorp and Quest Patient Service Centers will no longer conduct directly observed collections • Who it effects:Employers of both Zero Tolerance and Second Chance programs • What you need to do:Establish alternate collection site resources; and/or identify both a male and female representative from your agency that is willing to be an observer

35. Poll 3 Laboratory Patient Service Center

36. Poll 4 Directly Observed Collection

37. Action Items for Employers

38. Action Items for Employers • Policy Items that MUST be addressed: • Specimen Validity Testing Required • Addition of three new behaviors that constitute a refusal to test • Circumstances that lead to a directly observed collection • Directly observed collection procedures “will be in accordance with 49CFR Part 40, as amended” • If second chance: RTD and Follow Up direct observation option

39. Action Items for Employers • Contact collection sites; ask if they are aware of the changes to Part 40 and how they would handle a directly observed collection • Identify an Agency Representative who is willing to be an observer when a routine collection at a PSC turns into a DOC (you’ll need one male & one female)

40. Five of the Most Common Areas of Non-Compliance And how to avoid them!

41. #1Most Common Area of Non-Compliance • Collection Sites: the weakest link • Collection Site compliance= your compliance • Provide collectors with DOT collection guidelines and awareness resources (such as the new DOT video: 10 Steps to Collection Site Security and Integrity available on the ODAPC website) • Inspect sites for security measures • Audit the site informally when you are called for testing (reference: FDOT’s Collection Site Monitoring Toolkit) • Conduct unannounced visits that include an interview with a site staff member

42. #2 Most Common Area of Non-Compliance • Random Testing • Must cover all hours of operation and all days of operation (weekends and holidays) • Must be spread throughout entire testing period • Never “group test” • Never give advanced notice to employees • Use alternate selections properly • Cancelled tests do not count toward minimums • Update employee testing pool prior to each draw

43. # 3 Most Common Area of Non-Compliance • Post Accident Testing Decisions • Use decision and documentation form every time- whether or not you test • Use only the FTA criteria to decide to test/or not • Always conduct BOTH drug and alcohol tests • Train your supervisors • Make arrangements in advance for after hours testing resources • Conduct NON DOT testing if your agency feels testing is always necessary following an accident

44. #4 Most Common Area of Non-Compliance • Policy Issues: • Substance Abuse Policy does not include all of the FTA required elements • Policy items included under an agency’s own authority contradict DOT/FTA regulations (e.g.; FTA post accident criteria not used– testing conducted in all cases) • Failure to document employee receipt of policy revisions/updates

45. # 5 Most Common Area of Non-Compliance • Pre-employment Background Checks-40.25 • Get consent form signed by employee (see handout) • Check with DOT covered employers going back 2 years • Positive drug tests, Positive alcohol tests or any refusals to test • Make at least three attempts, document attempts • If employee’s past reveals a previous violation, employee must complete SAP evaluation, treatment and RTD before performing s-s duty

46. Resources for Further Information

47. Resources • ODAPC website: http://www.dot.gov/ost/dapc/video.html • What to get here: • New video and posters on collection site security and integrity • Collection instructions for direct observation • DOT Employer and DOT Employee Handbooks about the drug and alcohol testing program • Updated Part 40 and FAQs • List of certified labs

48. Resources Continued • FDOT/CUTR Substance Abuse Management Resource Site http://www.cutr.usf.edu/byrnessamsite • What to get here: • FDOT Model Policies for Zero Tolerance and Second Chance agencies • Collection Site Monitoring Toolkit • Collector Questionnaire for Employer-Collector Interview • Training Presentations • Notices of Upcoming Training Opportunities • Clean, Sober and Safe training video

49. This concludes our session~Thank you for joining us! Please feel free to contact me: Diana Byrnes byrnes@cutr.usf.edu 813-426-6980