Collection Site Inspections

1. FTA Drug & Alcohol Program National Conference Nashville, TN April 7-9, 2009 Joseph Lofgren FTA Audit Team Leader Collection Site Inspections

2. Why Inspect?

3. Vendor Oversight – Collections

4. 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 Collection Site Visits – FTA Method

5. 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 FTA Method - Pros

6. Best collector provides demonstration • 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 FTA Method - Cons

7. Begin with: • FTA Collection Site Questionnaires (http://transit-safety.volpe.dot.gov/DrugAndAlcohol/TechnicalAssistance/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 Collection Site Visits

8. There are two components to collection site inspection: • Mock collection • Unusual collections discussion Collection Site Visits

9. 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 Collection Site Visits

10. 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 Collection Site Visits

11. Collection Site VisitsA quick guide to beginning a mock collection

12. The Breath Alcohol Test §40.211-§40.279

13. Request photo ID (if not done already) • Use a Federal Alcohol Testing Form (ATF)? • Complete the form correctly and in order? • 1-2-3-(4) • Use a NHTSA-approved EBT (breath device) or ASD (saliva testing device)? Does the BA Technician (BAT):

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

15. Have a copy of the Quality Assurance Plan (QAP) for the device (EBT) used? • Have a copy of 49 CFR Part 40? • Understand how to load and troubleshoot problems with the device? Does the BAT/Site:

16. 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.? Does the BAT:

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

18. 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 Does the collector:

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

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

21. 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) Does the collector:

22. Are all concealment areas secured or removed? • Are all chemicals and fluids removed? • Are the ceiling tiles accessible? Once in the enclosure:

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

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

25. Provide a clean and suitable writing surface? • Use a Federal CCF? • Ensure all steps completed correctly on the CCF? • Don’t forget: 1, 2, 3, 5, 4! Does the collector:

26. Demonstration of Correct CCF Steps

27. - Steps 1 & 2

28. What’s Wrong or Missing?

32. Place specimen label seals on bottle? • Date the seals? • Instruct the donor to initial the seals? Does the collector:

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

34. Shy Bladders • Uncooperative donor • Direct Observation Discussion Topics

35. 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 Shy Bladder

36. 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! Uncooperative Donors

37. 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 Direct Observation

38. 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) Direct Observation Cont.

39. 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 Discussion Topics

40. 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? Does the site:

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

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

43. Get questionnaires (http://transit-safety.volpe.dot.gov/DrugAndAlcohol/TechnicalAssistance/default.asp or Audit Team Leader) • Make an appointment • Visit & evaluate • Require corrective actions • Give them a due-date! • Re-visit Next steps:

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

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

46. Questions & Answers Joe Lofgren will be available for questions immediately following this presentation Room 209-210