1. Collection Site Inspections FTA Drug & Alcohol Program National Conference Joseph Lofgren FTA Audit Team Leader Saint Louis, MO April, 2011

2. Why Inspect? Central Role Collection Sites are final and central component to entire D&A program Highest likelihood of technical flaws (most regs to follow) Cheating US GAO found 75% of inspected sites failed basic security/integrity procedures Lowest-paid technicians Users have most to lose, always a step ahead Oversight Tens of thousands of sites Millions of tests per year

3. Why Inspect? FTA Under- cover FTA has begun a full-fledged clandestine collection site inspection program How will your site do? FAIL STATS 27% have failed to identify donor 42% have failed to check pockets 38% have failed to require hand washing Bad Sites 24% reviewed showed critical failures Your employees deserve better

4. Why Inspect?

5. Vendor Oversight – Collections The Traveling Public US Congress US DOT FTA DAPM UrCo/ BAT

6. Collection Site Visits – FTA Method  Scheduled up to one month ahead of time  Open Process  Instruction/Seminar Format  Identity & Purpose clearly stated  Includes academic review of scenarios (non-normal collections)  ‘Mock’ sample

7. FTA Method - Pros  Inspector carries questionnaire  Can get a thorough understanding of collection site policy and collector’s knowledge  Can openly inspect equipment, facility, and security of enclosure  Can openly inspect credentials and certifications

8. FTA Method - Cons  Best collector provides demonstration (the Ringer)  Dynamic can be so uncomfortable for a nervous collector that mistakes may be compounded  Rest of process missing  Errors collector usually makes might be fixed by nature of mock Dr. A. Ringer, M.D.

9. Collection Site Visits  Begin with:  FTA Collection Site Questionnaires (http://transit- safety.fta.dot.gov/DrugAndAlcohol/TechnicalAss istance/AuditQuestions/default.asp)http://transit- safety.fta.dot.gov/DrugAndAlcohol/TechnicalAss istance/AuditQuestions/default.asp  Both Drug and Alcohol questionnaires available  Set a date  Familiarize fully yourself with the questionnaire  A review of CCFs/ATFs from site beforehand is extremely helpful

10. Collection Site Visits  There are two components to collection site inspection: 1.Mock collection 2.Unusual collections discussion

11. Collection Site Visits  Mock Collection  A demonstration of procedures used during normal/uneventful collections  Corrections should be conveyed after the mock  Collector should perform mock just as he or she normally would

12. Collection Site Visits  Unusual collections review  Is an academic discussion covering scenarios specifically described in 49 CFR Part 40 Shy Bladder Refusals Direct Observation And More!  Does not usually include demonstrations

13. Collection Site Visits A quick guide to beginning a mock collection

14. The Breath Alcohol Test §40.211-§40.279

15. Does the BA Technician (BAT):  Request photo ID (if not done already)  Use a Federal Alcohol Testing Form (ATF)?  NEW Form (#DOT F 1380/ OMB #2105-0529)  Mandatory implementation 1/1/2011.  Complete the form correctly and in order?  1-2-3-(4)  Use a NHTSA-approved EBT (breath device) or ASD (saliva testing device)?

16. Does the BAT/Site:  Have certifications and training records?  Keep regular accuracy checks recorded?  Maintain their equipment as required?

17. Does the BAT/Site:  Have a copy of the Quality Assurance Plan (QAP) for the device (EBT) used?  Have a copy of 49 CFR Part 40?  Current version 10/1/2010  Understand how to load and troubleshoot problems with the device?

18. Does the BAT:  Have an EBT for confirmation tests if they use saliva test or non-evidential breath testing device?  Have any experience with positive tests?  Understand special circumstances, such as refusals, fatal flaws, etc.?

19. The Urine Drug Collection §40.31-§40.73 & §40.191- §40.209

20. Does the collector:  Request photo ID (if not done already)  Instruct donor to remove outer garments?  Instruct donor to empty pockets?  Allow the donor to keep wallet?  Explain the procedures? Including showing the donor the instructions printed on the back of the form

21. Does the collector:  Ask donor to wash hands?  Secure all internal water sources?  Open sealed specimen containers in front of donor  Give donor a 55ml container?

22. Does the collector:  Instruct the donor to remain within site of the collector?  Inspect the enclosure?  Add bluing to the toilet?

23. Does the collector:  Give the donor a 4-minute time limit? NOTE: This presentation describes MOCK- collections only. Auditors recommend using a water specimen (low temperature reading can be disregarded)

24. Once in the enclosure:  Are all concealment areas secured or removed?  Are all chemicals and fluids removed?  Are the dropped-ceiling tiles secure? >Twelve pieces of paraphernalia found at this major US airport collection site.

25. Once in the enclosure:  Are there windows, doors, panels, or pass-through ports?  Is the toilet tank lid secured?  Is the water off?

26. Does the collector:  Check the temperature strip?  Check the quantity?  Distribute the specimen into each of 2 bottles?

27. Does the collector:  Provide a clean and suitable writing surface?  Use a Federal CCF?  NEW Federal CCF must be used starting Oct 1, 2011  In the meantime, collector must write name of agency (e.g. FTA) in Step 2  Ensure all steps completed correctly on the CCF?  Don’t forget: 1, 2, 3, 5, 4 !

28. Demonstration of Correct CCF Steps

29. Steps 1 & 2

30. What’s Wrong/Missing?

32. 32

33. 33

34. Does the collector:  Place specimen label seals on bottle?  Date the seals?  Instruct the donor to initial the seals?  And verify initials?

35. Does the collector:  Seal the specimens into a shipping bag?  Monitor only one donor at a time?

36. Discussion Topics  Shy Bladders  Uncooperative donor  Direct Observation

37. Shy Bladder  Donor must make initial attempt, even if:  Waiting for representative, or  “Just doesn’t have to go”  Donor has 3hrs to provide specimen  beginning with QNS cup  Donor may have up to 40 ounces of fluid over 3hrs  Doesn’t have to drink  Measurements must be:  Consistent  Accurate

38. Uncooperative Donors  If a donor is uncooperative:  Terminate test  Record actions in “Remarks” section  Call DER  This is a refusal to test  This goes for being uncooperative for directly observed or monitored tests as well… Collector is in Charge!

39. Direct Observation  If donor:  Removes tampering materials from pockets  Behaves in a way that “clearly indicates an attempt to tamper with a specimen”  Provides a specimen out of temp  Provides an adulterated/tampered specimen  Collector must require Direct Observation

40. Direct Observation Cont.  D.O. collection must occur immediately  Same-gender observer  Need not be a trained collector  Observer must: Require that donor disrobe (to chest, knees) and rotate to display absence of devices Watch urine travel from body to cup Record name on CCF (if not collector)

41. Discussion Topics  Frequency of courier Daily  Security of stored specimen No access by “civilians”  General facility security & privacy Back doors, lock boxes  Fixing Flaws Immediate or next business day  Collector training and retraining Mock collections in training 30 days to retrain after a Fatal Flaw

42. Does the site:  Have your correct phone number?  Transmit Copy 2 of the CCF directly to the MRO after each collection?  Welcome visits?  Exhibit consistent refresher training?  Afford donors confidentiality and privacy before, during, and after the collection?

43. Does the site:  Communicate directly with the DER?  Use the correct forms?  Understand the importance of the collection process as relates to your compliance?

44. Does the site:  Also perform other USDOT-regulated tests?  Have hours or availability that match company hours of safety-sensitive operations? Can they be flexible?

45. Next steps:  Get questionnaires ( http://transit- safety.fta.dot.gov/DrugAndAlcohol/TechnicalAssist ance/AuditQuestions/default.asp or Audit Team Leader ) http://transit- safety.fta.dot.gov/DrugAndAlcohol/TechnicalAssist ance/AuditQuestions/default.asp  Make an appointment  Visit & evaluate  Require corrective actions  Give them a due-date!  Re-visit

46. Remember: Your collection site  Should be willing to help you with your collection changes required  Should be accurate and exacting  Should be your partner in this process

47. Thank you Joseph Lofgren FTA Drug & Alcohol Audit Team