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FTA Drug & Alcohol Program National Conference. Universal City, CA March, 2010. Joseph Lofgren FTA Audit Team Leader. Collection Site Inspections. Why Inspect?. Why Inspect? . Vendor Oversight – Collections. Scheduled up to one month ahead of time Open Process

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collection site inspections
FTA Drug & Alcohol Program

National Conference

Universal City, CA

March, 2010

Joseph Lofgren

FTA Audit Team Leader

Collection Site Inspections
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
Collection Site Visits – FTA Method
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
FTA Method - Pros
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
FTA Method - Cons
collection site visits
Begin with:
    • FTA Collection Site Questionnaires (
    • Both Drug and Alcohol questionnaires available
    • Set a date
    • Familiarize yourself fully with the questionnaire
    • A review of CCFs/ATFs from site beforehand is extremely helpful
Collection Site Visits
collection site visits10
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
collection site visits11
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
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)?
Does the BA Technician (BAT):
does the bat site
Have certifications and training records?
  • Keep regular accuracy checks recorded?
  • Maintain their equipment as required?
Does the BAT/Site:
does the bat site16
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:
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.?
Does the BAT:
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:
does the collector20
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:
does the collector22
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:
once in the enclosure
Are all concealment areas secured or removed?
  • Are all chemicals and fluids removed?
  • Are the ceiling tiles accessible?

>Twelve pieces of paraphernalia found at this major US airport collection facility.

Once in the enclosure:
does the collector25
Check the temperature strip?
  • Check the quantity?
  • Distribute the specimen into each of 2 bottles?
Does the collector:
does the collector26
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:
does the collector33
Place specimen label seals on bottle?
  • Date the seals?
  • Instruct the donor to initial the seals?
Does the collector:
discussion topics
Shy Bladders
  • Uncooperative donor
  • Direct Observation
Discussion Topics
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
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
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
Direct Observation
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)
Direct Observation Cont.
discussion topics40
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
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:
does the site42
Communicate directly with the DER?
  • Use the correct forms?
  • Understand the importance of the collection process as relates to your compliance?
Does the site:
does the site43
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:
next steps
Get questionnaires ( or Audit Team Leader)
  • Make an appointment
  • Visit & evaluate
  • Require corrective actions
    • Give them a due-date!
  • Re-visit
Next steps:
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
Remember: Your collection site
thank you

Thank you

Joseph Lofgren

FTA Drug & Alcohol Audit Team