Collection Site InspectionsCollection Site Inspections

FTA Drug & Alcohol ProgramNational Conference

Joseph LofgrenFTA Audit Team Leader

Nashville, TN April 7-9, 2009

Why Inspect?Why Inspect?

Vendor Oversight – CollectionsVendor Oversight – Collections

Collection Site Visits – FTA MethodCollection 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

FTA Method - ProsFTA 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

FTA Method - ConsFTA Method - Cons

Best collector provides demonstrationDynamic 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

Collection Site VisitsCollection Site Visits

Begin with:FTA Collection Site Questionnaires (

http://transit-safety.volpe.dot.gov/DrugAndAlcohol/TechnicalAssistance/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

Collection Site VisitsCollection Site Visits

There are two components to collection site inspection:

1. Mock collection2. Unusual collections discussion

Collection Site VisitsCollection 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 VisitsCollection 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

Collection Site VisitsCollection Site Visits

A quick guide to beginning a A quick guide to beginning a mock collectionmock collection

The Breath Alcohol Test The Breath Alcohol Test §40.211-§40.279§40.211-§40.279

Does the BA Technician (BAT):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 BAT/Site: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/Site:

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: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 CollectionThe Urine Drug Collection§40.31-§40.73 &§40.31-§40.73 & §40.191- §40.209§40.191- §40.209

Does the collector: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 specimen containers in front of donor

Give donor a 55ml container?

Does the collector:Does the collector:

Instruct the donor to remain within site of the collector?

Inspect the enclosure?

Add bluing to the toilet?

Does the collector: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:Once in the enclosure:

Are all concealment areas secured or removed?

Are all chemicals and fluids removed?Are the ceiling tiles accessible?

Once in the enclosure: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: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!

Demonstration of Correct CCF Steps

Steps 1 & 2Steps 1 & 2

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28

What’s Wrong or Missing?

29

30

31

Does the collector:Does the collector:

Place specimen label seals on bottle?

Date the seals?

Instruct the donor to initial the seals?

Does the collector:Does the collector:

Seal the specimens into a shipping bag?

Monitor only one donor at a time?

Discussion TopicsDiscussion Topics

Shy Bladders

Uncooperative donor

Direct Observation

Shy BladderShy 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 DonorsUncooperative 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 ObservationDirect 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.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)

Discussion TopicsDiscussion 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: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?Use the correct forms?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?

Next steps:Next steps:

Get questionnaires (http://transit-safety.volpe.dot.gov/DrugAndAlcohol/TechnicalAssistance/default.asp

or Audit Team Leader)Make an appointmentVisit & evaluateRequire corrective actions

Give them a due-date!Re-visit

Remember: Remember: Your collection site Your collection site

Should be your partner in this process

Should be willing to help you with your collection changes required

Should be accurate and exacting

Thank youThank youJoseph Lofgren

FTA Drug & Alcohol Audit Team

Questions & Answers

Joe Lofgren

will be available for questions

immediately following this presentation

Room 209-210