FTA DRUG AND ALCOHOL PROGRAM NATIONAL CONFERENCE

How to Review Your Collection Site

for Compliance

Atlanta, GA 2015

Why Inspect?

Central Role• 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?FTA’s Clandestine Collections• FTA maintains a full-fledged clandestine collection site inspection program• How will your site do?

FAIL STATS• 7% have failed to identify donor• 36% have failed to check pockets• 31% have failed to require hand washing

Bad Sites• 9% reviewed showed critical failures• Your employees deserve better

Why Inspect?

Critical Flaws (L4) Serious Flaws (L3) Routine Flaws (L2) Admin Flaws (L1)0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Critical Flaws (L4); 9%

Serious Flaws (L3); 83%

Routine Flaws (L2); 74%

Admin Flaws (L1); 72%

Percentage of Inspections w/ Flaw Type

Includes 691 inspections through Dec. 2014

Traveling Public

US Congress

US DOT

FTA

DAPM

Collector

Collection Site Visits – FTA Method

Scheduled Open ProcessInstructional Identity & Purpose clearly statedIncludes discussion of “problem” collections/scenariosWater sample

Pros

QuestionnaireThorough understanding of policies, practices, knowledgeCan openly inspect equipment, facilityCan openly inspect credentials

Cons

The RingerDynamic can compound collector mistakes “Rest of process” missingSome errors fixed by nature of mock

Collection Site Visits

Begin with:

FTA Collection Site Questionnaires (http://transit-safety.fta.dot.gov/DrugAndAlcohol/tools)

Both Urine and Breath-Alcohol questionnaires availableSet a dateFamiliarize yourself with the questionnaire

(Call us if you have questions!) 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 (“problem”) 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

A discussion covering scenarios specifically described in 49 CFR Part 40Shy BladderRefusalsDirect ObservationAnd More!

Does not usually include demonstrations

The Breath Alcohol Test §40.211-§40.279

Does the Breath Alcohol 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 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.?

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:

Ask donor to wash hands?

Secure all internal water sources?

Open sealed kit in front of donor

Give donor a 55ml container?

Once in the enclosure:

Concealment areas secured or removed?

Chemicals and fluids removed?

Ceiling tiles secured?

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?

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?

What’s Wrong/Missing?

29

30

Does the collector:

Place specimen label seals on bottle?

Date the seals?

Instruct the donor to initial the seals?And verify initials?

54321

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 3hrsDoesn’t have to drinkMeasurements must be:

ConsistentAccurate

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!

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

Direct Observation Cont.

D.O. collection must occur immediatelyNo provision for waiting period, fluid intake

Same-gender observerNeed not be a collector or medical professional

Observer must:Require that donor disrobe (to chest, knees) and rotate to display absence of

devicesWatch urine travel from body to cupRecord name on CCF (if not collector)

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

Does the Site:

Have your correct contact information?

Transmit Copy 2 of the CCF directly to the MRO after each collection?

Afford donors confidentiality and privacy before, during, and after the collection?

Does the Site:

Welcome your visits?

Perform other USDOT-regulated tests?

Understand the importance of the collection process as relates to your compliance?

Next steps:

Get questionnaires http://transit-safety.fta.dot.gov/DrugAndAlcohol/tools

Make an appointmentVisit & evaluateRequire corrective actions

Give them a due date!Re-visit

Remember: Your collection site should be… Consistent and accurate

Your partner in the process

Willing to respond to your request for compliant practices

FTA Drug and Alcohol ProgramNATIONAL CONFERENCE

THANK YOU

Atlanta, GA 2015