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

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

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

Why Inspect?

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

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

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 - 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.

Collection Site Visits  Begin with:  FTA Collection Site Questionnaires ( safety.fta.dot.gov/DrugAndAlcohol/TechnicalAss istance/AuditQuestions/default.asp) 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

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

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  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 A quick guide to beginning a mock collection

The Breath Alcohol Test § §40.279

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 # )  Mandatory implementation 1/1/2011.  Complete the form correctly and in order?  (4)  Use a NHTSA-approved EBT (breath device) or ASD (saliva testing device)?

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

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?

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.?

The Urine Drug Collection §40.31-§40.73 & § §40.209

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

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)

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.

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

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

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 !

Demonstration of Correct CCF Steps

Steps 1 & 2

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?

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

Discussion Topics  Shy Bladders  Uncooperative donor  Direct Observation

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

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!

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 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)

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

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

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?

Next steps:  Get questionnaires ( safety.fta.dot.gov/DrugAndAlcohol/TechnicalAssist ance/AuditQuestions/default.asp or Audit Team Leader ) 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

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

Thank you Joseph Lofgren FTA Drug & Alcohol Audit Team