collection site inspections fta drug & alcohol program national conference joseph lofgren fta...
TRANSCRIPT
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Collection Site Inspections
FTA Drug & Alcohol Program
National Conference
Joseph LofgrenFTA Audit Team Leader
Saint Louis, MOApril, 2011
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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)
Cheatin
g
•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
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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 Site
s
•24% reviewed showed critical failures
•Your employees deserve better
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Why Inspect? Critical Flaws (L4) Serious Flaws (L3) Routine Flaws (L2) Procedural Flaws (L1)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Critical Flaws (L4); 24%
Serious Flaws (L3); 95%
Routine Flaws (L2); 92%
Procedural Flaws (L1);
78%
Percentage of Sites With Given Flaw
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Vendor Oversight – CollectionsThe Traveling Public
US Congress
US DOT
FTA
DAPM
UrCo/ BAT
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Collection Site Visits – FTA Method
Scheduled up to one month ahead of timeOpen ProcessInstruction/Seminar FormatIdentity & Purpose clearly statedIncludes academic review of scenarios
(non-normal collections)‘Mock’ sample
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FTA Method - Pros
Inspector carries questionnaireCan 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
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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 missingErrors collector usually makes might be fixed by nature of mock
Dr. A. Ringer, M.D.
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Collection Site Visits
Begin with:FTA Collection Site Questionnaires (
http://transit-safety.fta.dot.gov/DrugAndAlcohol/TechnicalAssistance/AuditQuestions/default.asp)
Both Drug and Alcohol questionnaires availableSet a dateFamiliarize fully yourself with the questionnaire A review of CCFs/ATFs from site beforehand is
extremely helpful
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Collection Site Visits
There are two components to collection site inspection:
1. Mock collection2. Unusual collections discussion
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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
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Collection Site Visits
Unusual collections reviewIs an academic discussion covering scenarios
specifically described in 49 CFR Part 40Shy BladderRefusalsDirect ObservationAnd More!
Does not usually include demonstrations
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Collection Site Visits
A quick guide to beginning a mock collection
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The Breath Alcohol Test §40.211-§40.279
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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)?
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Does the BAT/Site:
Have certifications and training records?
Keep regular accuracy checks recorded?
Maintain their equipment as required?
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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?
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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.?
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The Urine Drug Collection§40.31-§40.73 & §40.191- §40.209
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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
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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?
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Does the collector:
Instruct the donor to remain within site of the collector?
Inspect the enclosure?
Add bluing to the toilet?
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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)
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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.
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Once in the enclosure:
Are there windows, doors, panels, or pass-through ports?
Is the toilet tank lid secured?
Is the water off?
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Does the collector:
Check the temperature strip?
Check the quantity?
Distribute the specimen into each of 2 bottles?
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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!
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Demonstration of Correct CCF Steps
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Steps 1 & 2
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What’s Wrong/Missing?
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What’s Wrong/Missing?
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Does the collector:
Place specimen label seals on bottle?
Date the seals?
Instruct the donor to initial the seals?And verify initials?
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Does the collector:
Seal the specimens into a shipping bag?
Monitor only one donor at a time?
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Discussion Topics
Shy Bladders
Uncooperative donor
Direct Observation
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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 3hrsDoesn’t have to drinkMeasurements must be:
ConsistentAccurate
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Uncooperative Donors
If a donor is uncooperative:Terminate testRecord actions in “Remarks” sectionCall DER
This is a refusal to testThis goes for being uncooperative for
directly observed or monitored tests as well… Collector is in Charge!
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Direct Observation
If donor:Removes tampering materials from pocketsBehaves in a way that “clearly indicates an
attempt to tamper with a specimen”Provides a specimen out of tempProvides an adulterated/tampered specimen
Collector must require Direct Observation
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Direct Observation Cont.
D.O. collection must occur immediatelySame-gender observer
Need not be a trained collectorObserver must:
Require that donor disrobe (to chest, knees) and rotate to display absence of devices
Watch urine travel from body to cupRecord name on CCF (if not collector)
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Discussion Topics
Frequency of courierDaily
Security of stored specimenNo access by “civilians”
General facility security & privacyBack doors, lock boxes
Fixing FlawsImmediate or next business day
Collector training and retrainingMock collections in training30 days to retrain after a Fatal Flaw
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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?
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Does the site:
Communicate directly with the DER?Use the correct forms?Understand the importance of the
collection process as relates to your compliance?
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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?
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Next steps:
Get questionnaires (http://transit-safety.fta.dot.gov/DrugAndAlcohol/TechnicalAssistance/AuditQuestions/default.asp
or Audit Team Leader)Make an appointmentVisit & evaluateRequire corrective actions
Give them a due-date!Re-visit
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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
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Thank youJoseph Lofgren
FTA Drug & Alcohol Audit Team