Transcript Slide 1
Substance Abuse Management
Regulatory Updates
Tuesday March 31, 2009
Distance Learning Session
Welcome
• Diana Byrnes, Substance Abuse
Management Specialist
• Center for Urban Transportation Research
(CUTR)
• Project Manager for the FDOT Substance
Abuse Management Oversight and
Technical Assistance Program
• Transportation Safety Institute Associate Staff
Instructor
• Certified Substance Abuse Program
Administrator (C-SAPA)
Distance Learning - Things to Remember
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Course Goal
• To inform you of the drug and alcohol
testing regulation amendments that
went into effect on August 25, 2008
• To educate you in key areas of
potential non-compliance within your
testing program
Poll 1
Participant Level of Experience
Basics of Drug and Alcohol Testing
• Regulations:
49 CFR Part 655 Federal Transit
Administration: Prevention of Alcohol
Misuse and Prohibited Drug Use in Transit
Operations
49 CFR Part 40 US DOT Procedures for
Transportation Workplace Drug and
Alcohol Testing Programs
What does Part 655 tell us?
• Defines Covered Employers
• Defines Covered Employees
• Defines the circumstances in which testing
must occur (such as random rate, post accident
criteria)
• Establishes regulations concerning policy
and training requirements
• Defines the consequences for positive results
and refusals to test (removal from s-s duty)
• Conditions financial assistance to
compliance (per OTETA)
What does Part 40 tell us?
• The required procedures for the collection,
analysis, MRO review, and reporting of drug
and alcohol specimens
• Safeguards the integrity of the program by
establishing specific procedures for each
step of the process
• Must be consistent with US Department of
Health and Human Services guidelines for
federal workplace drug testing
Basics of Drug and Alcohol Testing
• Test Types
– Pre-employment (urine drug required, breath
alcohol allowed)
– Random (minimum rate is 25% urine drug 10%
breath alcohol)
– Post Accident (must always do both drug and
alcohol!)
– Reasonable Suspicion (urine drug or breath
alcohol-depends on nature of suspicion)
– Return to Duty (follow SAP instructions for test
types)
– Follow Up (follow SAP instructions for test type
and frequency)
Basics of Drug Testing
• DOT urine drug testing panel includes
these five prohibited substances:
• Amphetamines
• Cocaine
• Marijuana
• Opiates
• PCP
DOT panel can only include these five
Hair and blood are not acceptable DOT
specimens
Basics of Urine Collection
• Collectors must meet training qualifications
in accordance with 40.33
• A Federal CCF must be used for all DOT
collections
• DOT urine collections must be “split”
• Privacy enclosure must be free of potential
contaminating agents, water sources and
“hiding spots”
• Bluing agent must be present in toilet water
• Collection site must be secure (restricted
access)
Basics of Laboratory
• Labs must be certified by DHHS
(Department of Health and Human
Services)
• A list is of certified labs is updated
every month and published in the
Federal Register during the first week of
each month.
What happens at the Lab ?
• Accessioning of specimen
– Inspect condition of specimen
– Review CCF for fatal or correctable flaws
• Initial screening by immunoassay,
includes specimen validity testing
• Negative results report out
• Non-negative results move on for
further testing
Lab results reported to MRO
• Negative Dilute with creatinine level
between 5 and 20 ng/ml
• Negative Dilute with creatinine level
between 2 and 5 ng/ml
• Positive or Positive Dilute
• Adulterated
• Substituted
• Invalid
The Role of the MRO
• MRO is the gatekeeper
– Impartial, independent; protects the integrity of
the testing process
– Inspects MRO and Lab copies of CCF for errors
– Obtains lab report inclusive of quantitative data
– Interviews donor via telephone or in person
– Recites Medical Miranda to donor
– Verifies possible medical explanations
– Has the authority to order additional testing,
cancel a test, or deem a test to be invalid
– Has the final word! Drug test results cannot be
changed by anyone other than the MRO
Results from MRO
Negative- no further action required, employee may
begin or resume s-s duty
Negative Dilute- follow policy regarding retesting,
follow MRO instruction to recollect under direct
observation (when creatinine in the 2-5 range)
Positive with drug listed- remove employee
immediately from s-s duty, follow policy
Positive Dilute- POSITIVE, see above
Cancelled- must be considered neither positive nor
negative (follow MRO instruction, recollect under direct
observation, second collection or no further action)
Refusal to Test because of Adulterated or Substitutedremove employee from s-s duty, follow policy
Regulatory Updates
Effective August 25, 2008
Video
SpikeTV: Manswers
Available Products
GOOGLE Results 1 - 10 of about 1,040,000 for beat a drug
test. (0.18 seconds)
Prosthetic Devices
Amendments- Background
• Overall purpose:
– To make DOT required drug testing harder to
“beat”.
– To require specimen validity testing at all DHHS
certified laboratories
– To enhance the direct observation procedures
• The manufacturing of adulterants, urine
substitutes and prosthetic devices have
made this necessary
Breakdown of Amendments to Part 40
Specimen Validity Testing Required-40.89
What it means: Laboratories must test
specimens for adulterants and
substitutions using DHHS guidelines
Who does it effect: Labs
What you need to do: Update your
policy to reflect this change (FL DOT
Model Policy includes this is Section 16)
Breakdown of Amendments to Part 40
Direct Observation Procedures Change
What it means: Whenever there is a
specific reason to believe a donor is
attempting to tamper with or evade a
test, a recollection under direct
observation must take place
Who does it effect: Donors and
Collectors
What you need to do: Make policy
changes (FL DOT Model Policy includes this in
Section 15)
Breakdown of Amendments to Part 40
Three new behaviors that constitute a
Refusal to Test
What does this mean: additional measures
taken to secure the process from those
attempting to evade or tamper with tests
Who does this effect: Donors, collectors,
employers
What you need to do: You MUST include all
of the behaviors in your policy (FL DOT
Model Policy lists them in Section 14)
Breakdown of Amendments to Part 40
MRO can use a medical evaluation to
determine prohibited drug use following an
invalid result
What it means: When a (-) result is required
and only an invalid result can be produced
via urine, this provides a means to obtaining a
negative result
Who it effects: Donors who produce invalid
results, MROs, Employers
What do you need to do: Add this language
to your policy (FL DOT Model addresses this in
Section 20)
Breakdown of Amendments to Part 40
Negative Dilute Retesting
What it means: When a negative dilute
result with a creatinine level between 5ng/ml
and 20 ng/ml is reported; you are authorized
to conduct a second collection. The second
collection may not be directly observed and
is the final result.
Who it effects: Donors, Employers
What do you need to do: Add this
language to your policy, implement
consistently (reference FL DOT Model Section 17)
Additional Information Regarding Negative Dilute Results
Negative Dilute Results with a creatinine
level between 2 and 5 ng/ml require retest
under direct observation
What it means: Specimen that the human
body can rarely produce
Who does it effect: Donors, collectors,
Employers
What do you need to do: Check results
carefully, when levels are not indicated,
contact MRO. Always follow MRO
instructions on how to proceed
Breakdown of Amendments to Part 40
No Split Testing of Invalid results
What it means: Donors will not be able to
request that their B bottle (split specimen)
be tested at another lab when the A bottle
produced an invalid result
Who it effects: Donors with invalid results
What you need to do: add statement to
policy (reference FL DOT Model Policy Section 21)
Breakdown of Amendments to Part 40
Stop Publication of Lab Methods
What it means: laboratory testing and
analysis methods will no longer be
published
Who it effects: The multi-million dollar
industry that manufactures products
designed to “beat” DOT drug tests!
What you need to do: Nothing
Breakdown
Lab Reports to DOT
What does it mean: drug testing
laboratories must report to DOT semiannual statistical summaries on all of
their DOT testing
Who does it effect: Labs and DOT
What do you need to do: Nothing
Poll 2
Zero Tolerance vs 2nd Chance
Return to Duty and Follow Up Tests
At this time there is an Administrative Stay on
making these test types mandatory direct
observation collections
What does this mean: Employer Option still remains
to conduct these tests under direct observation
Who does this effect: Second Chance Employers
What do you need to do: Determine if your agency
would like to exercise the option; add it to your
policy; apply it consistently (FDOT Model Policy for
Second Chance Agencies exercises this option)
This concludes the Amendments
Anticipated Problem
No D.O.C.’s @ P.S.C.’s
What it means: LabCorp and Quest Patient
Service Centers will no longer conduct
directly observed collections
Who it effects: Employers of both Zero
Tolerance and Second Chance programs
What you need to do: Establish alternate
collection site resources; and/or identify
both a male and female representative
from your agency that is willing to be an
observer
Poll 3
Laboratory Patient Service Center
Poll 4
Directly Observed Collection
Action Items for Employers
Action Items for Employers
• Policy Items that MUST be addressed:
– Specimen Validity Testing Required
– Addition of three new behaviors that
constitute a refusal to test
– Circumstances that lead to a directly
observed collection
– Directly observed collection procedures
“will be in accordance with 49CFR Part 40,
as amended”
– If second chance: RTD and Follow Up
direct observation option
Action Items for Employers
• Contact collection sites; ask if they are
aware of the changes to Part 40 and
how they would handle a directly
observed collection
• Identify an Agency Representative
who is willing to be an observer when
a routine collection at a PSC turns into
a DOC (you’ll need one male & one
female)
Five of the Most Common Areas
of Non-Compliance
And how to avoid them!
#1Most Common Area of Non-Compliance
• Collection Sites: the weakest link
– Collection Site compliance= your compliance
– Provide collectors with DOT collection guidelines
and awareness resources (such as the new DOT video:
10 Steps to Collection Site Security and Integrity available on the
ODAPC website)
– Inspect sites for security measures
– Audit the site informally when you are called for
testing (reference: FDOT’s Collection Site
Monitoring Toolkit)
– Conduct unannounced visits that include an
interview with a site staff member
#2 Most Common Area of Non-Compliance
• Random Testing
– Must cover all hours of operation and all days of
operation (weekends and holidays)
– Must be spread throughout entire testing period
– Never “group test”
– Never give advanced notice to employees
– Use alternate selections properly
– Cancelled tests do not count toward minimums
– Update employee testing pool prior to each
draw
# 3 Most Common Area of Non-Compliance
• Post Accident Testing Decisions
– Use decision and documentation form every
time- whether or not you test
– Use only the FTA criteria to decide to test/or not
– Always conduct BOTH drug and alcohol tests
– Train your supervisors
– Make arrangements in advance for after hours
testing resources
– Conduct NON DOT testing if your agency feels
testing is always necessary following an accident
#4 Most Common Area of Non-Compliance
• Policy Issues:
– Substance Abuse Policy does not include
all of the FTA required elements
– Policy items included under an agency’s
own authority contradict DOT/FTA
regulations (e.g.; FTA post accident criteria not used–
testing conducted in all cases)
– Failure to document employee receipt of
policy revisions/updates
# 5 Most Common Area of Non-Compliance
• Pre-employment Background Checks-40.25
– Get consent form signed by employee (see
handout)
– Check with DOT covered employers going back
2 years
– Positive drug tests, Positive alcohol tests or any
refusals to test
– Make at least three attempts, document
attempts
– If employee’s past reveals a previous violation,
employee must complete SAP evaluation,
treatment and RTD before performing s-s duty
Resources for Further Information
Resources
• ODAPC website:
http://www.dot.gov/ost/dapc/video.html
What to get here:
New video and posters on collection site
security and integrity
Collection instructions for direct observation
DOT Employer and DOT Employee Handbooks
about the drug and alcohol testing program
Updated Part 40 and FAQs
List of certified labs
Resources Continued
• FDOT/CUTR Substance Abuse
Management Resource Site
http://www.cutr.usf.edu/byrnessamsite
What to get here:
FDOT Model Policies for Zero Tolerance and Second
Chance agencies
Collection Site Monitoring Toolkit
Collector Questionnaire for Employer-Collector
Interview
Training Presentations
Notices of Upcoming Training Opportunities
Clean, Sober and Safe training video
This concludes our session~
Thank you for joining us!
Please feel free to contact me:
Diana Byrnes
[email protected]
813-426-6980