1. Collection Site Inspections
FTA Drug & Alcohol Program National Conference
Little Rock
April, 2014
Joseph Lofgren
FTA Audit Team Leader
Collection Site Inspections

2. Why Inspect? Central Role Cheating Oversight
Collection Sites are final and central component to D&A program
Highest likelihood of technical flaws (most regs to follow)
Cheating
Many sites fail basic security/integrity procedures
Users have most to lose, always a step ahead
Oversight
Thousands of sites
Millions of tests per year
Why Inspect?

3. Why Inspect? FTA Under-cover FAIL STATS Bad Sites
FTA maintains a full-fledged clandestine collection site inspection program
How will your site do?
FAIL STATS
7% have failed to identify donor
38% have failed to check pockets
32% have failed to require hand washing
Bad Sites
10% reviewed showed critical failures
Your employees deserve better
Why Inspect?

4. Why Inspect?
Includes 552 inspections through Dec. 2013

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

6. Collection Site Visits – FTA Method
Scheduled ahead of time
Open Process
Instructional Format
Identity & Purpose clearly stated
Includes discussion of “problem” collections/scenarios
Water sample
Collection Site Visits – FTA Method

7. FTA Method - Pros Questionnaire
Thorough understanding of policies, practices, knowledge
Can openly inspect equipment, facility
Can openly inspect credentials
FTA Method - Pros

8. FTA Method - Cons The Ringer Dynamic can compound collector mistakes
Rest of process missing
Dr. T. Ringer, M.D.
Errors collector usually makes might be fixed by nature of mock
FTA Method - Cons

9. Collection Site Visits
Begin with:
FTA Collection Site Questionnaires ( safety.fta.dot.gov/DrugAndAlcohol/TechnicalAssista nce/default.asp)
Both Urine and Breath-Alcohol questionnaires available
Set a date
Familiarize yourself with the questionnaire
(Call us if you have questions!)
A review of CCFs/ATFs from site beforehand is extremely helpful
Collection Site Visits

10. Collection Site Visits
There are two components to collection site inspection:
Mock collection
Unusual (“problem”) collections discussion
Collection Site Visits

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
Collection Site Visits

12. Collection Site Visits
Unusual collections review
A 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

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

14. The Breath Alcohol Test §40.211-§40.279
Alcohol test first?

15. Does the BA Technician (BAT):
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)?
NHTSA Ref:
Does the BA Technician (BAT):

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

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

18. 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.?
List fatal flaws for alcohol tests: Display/PO different; No 15-mins wait; No air blank/air blank not 0.00; No printout; Out of cal
Does the BAT:

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
Does the collector:

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

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

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

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

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

26. Does the collector: 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!
Fed/Forensic form similarities;
Does the collector:

27. Demonstration of Correct CCF Steps

28. Steps 1 & 2

29. What’s Wrong/Missing?

30. What’s Wrong/Missing?

31. Courier; else ok

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

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

35. Shy Bladders
Uncooperative donor
Direct Observation
Discussion Topics

36. 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
Shy Bladder

37. 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!
Uncooperative Donors

38. Direct Observation If donor: Collector must require Direct Observation
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

39. Direct Observation Cont.
D.O. collection must occur immediately
Same-gender observer
Need not be a collector or medical professional
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.

40. Discussion Topics Frequency of courier Security of stored specimen
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

41. 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?
Does the site:

42. Does the site: Communicate directly with the DER?
Understand the importance of the collection process as relates to your compliance?
Does the site:

43. 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?
Does the site:

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

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

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