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

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?

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?

Why Inspect? Includes 552 inspections through Dec. 2013

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

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

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

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

Collection Site Visits Begin with: FTA Collection Site Questionnaires (http://transit- 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

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

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

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

Collection Site Visits A quick guide to beginning a mock collection

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

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):

Does the BAT/Site: Have training/qualification 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 current copy of 49 CFR Part 40? Understand how to load and troubleshoot problems with the device? Does the BAT/Site:

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:

The Urine Drug Collection §40.31-§40.73 & §40.191- §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:

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:

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

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:

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

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

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:

Demonstration of Correct CCF Steps

Steps 1 & 2

What’s Wrong/Missing?

What’s Wrong/Missing?

Courier; else ok

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:

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

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: 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

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.

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

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

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:

Get questionnaires (http://transit- safety. fta. dot Get questionnaires (http://transit- 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:

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

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