Collection Site Inspections

FTA Drug & Alcohol Program

National Conference

Joseph LofgrenFTA Audit Team Leader

Saint Louis, MOApril, 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)

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

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

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

Vendor Oversight – CollectionsThe Traveling Public

US Congress

US DOT

FTA

DAPM

UrCo/ BAT

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

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

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.

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

Collection Site Visits

There are two components to collection site inspection:

1. Mock collection2. 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 reviewIs an academic discussion covering scenarios

specifically described in 49 CFR Part 40Shy BladderRefusalsDirect ObservationAnd More!

Does not usually include demonstrations

Collection Site Visits

A quick guide to beginning a mock collection

The Breath Alcohol Test §40.211-§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 #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)?

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 & §40.191- §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 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?

What’s Wrong/Missing?

32

33

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 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 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 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 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 (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

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 youJoseph Lofgren

FTA Drug & Alcohol Audit Team