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OTETA Omnibus Transportation Employee Testing Act Regulatory Update. FAPT July 2009 Dr. Donna Smith FirstLab, Inc. dsmith@firstlab.com. Part 40 Amendments. Final Rule June 08; effective 08-25-08 Specimen validity testing mandatory

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oteta omnibus transportation employee testing act regulatory update

OTETA Omnibus Transportation Employee Testing Act Regulatory Update

FAPT July 2009

Dr. Donna Smith

FirstLab, Inc.

dsmith@firstlab.com

part 40 amendments
Part 40 Amendments
  • Final Rule June 08; effective 08-25-08
    • Specimen validity testing mandatory
    • Direct observation procedures for specimen collection modified
    • Changes for MRO interpretation and reporting of multiple invalid specimen results; multiple specimens collected at one testing event; multiple results on a specimen
specimen validity testing svt
Specimen Validity Testing (SVT)
  • Mandatory for all DOT drug testing
  • Minimum SVT requirements for laboratory
    • Creatinine (if less than 20 must also measure Specific Gravity)
    • pH
    • One or more oxidizing agents
  • Criteria for adulterated, substituted and invalid remain the same
invalid specimens
Invalid Specimens
  • DOT has adopted the DHHS guidance to laboratories for what they report as “invalid Specimen”
    • 12 circumstances that require laboratory to report a specimen as invalid
  • MRO has responsibility for discussing an invalid result with the certifying scientist before interviewing the donor
    • Purpose of this discussion is to determine if additional testing of the specimen at another laboratory is beneficial
invalid specimen
Invalid Specimen
  • Donor interview is to determine if there is a medical explanation for the circumstances that rendered the specimen invalid
    • If there is no medical explanation, the test is cancelled and an immediate re-collection under direct observation procedures is required
    • If there is a medical explanation for the invalid specimen (e.g. medication interference), the test is cancelled and there is no recollection of a specimen
  • If donor admits to drug use, the MRO must write and sign a statement documenting the donor’s admission and report same to DER
    • Test is cancelled
  • If donor admits to attempting adulteration, the MRO will report the result as a refusal to test
direct observation collections
Direct Observation Collections
  • Direct Observation required in the following circumstances:
    • Donor presents a specimen with temperature out of range
    • Donor presents a specimen that collector believes was adulterated or substituted
    • MRO cancels a test and requires a re-collection of a specimen because-
      • Specimen creatinine was 2-5 mg/dL
      • Specimen was invalid and there was no medical explanation
      • Split specimen was requested and was not available for reconfirmation
    • If test is a DOT Return to Duty or Follow-up Test
      • Implementation of this provision is on hold pending resolution of court decision
direct observation procedures
Direct Observation Procedures
  • Direct observation procedure provides for more visual scrutiny by observer/collector
    • Donor must position clothing so that the observer can view the donor’s body from above the waist to mid-thigh (front & back)—to check for a urine substitution or adulteration devise.
    • After inspection, the donor may reposition clothing and provide specimen with observer directly observing the urine leaving the body into the collection container
multiple results on a specimen
Multiple Results on a Specimen
  • If specimen is both positive and adulterated or substituted, MRO reports both positive and refusal to test determinations for the test
  • If specimen is verified as positive and/or refusal to test and is also invalid, MRO does not cancel test or report specimen invalidity
  • Positive dilute is reported to DER, however no re-collection is authorized
fmcsa 49 cfr part 382
FMCSA 49 CFR Part 382
  • No changes to Part 382 in past 2 years
  • Random testing rates for Drug and Alcohol testing for 2009 remain the same (50%-drug, 10%-alcohol)
  • Random testing
    • Must do random selections at least 4 times per year
    • Must test all selected drivers during the selection period (quarter, month, etc.)
      • Can only use “alternate selection(s)” if selected drivers are unavailable for the entire selection period (e.g. terminated, laid-off, long term disability, etc.)
    • Cannot give prior notice for random testing—must be tested immediately after being notified
fmcsa 49 cfr part 38210
FMCSA 49 CFR Part 382
  • Reminders for Part 40 & 382 compliance
    • Make sure policy is current
      • Negative dilutes
      • Invalid/cancelled tests
      • Refusal to test definitions
      • Actions taken on MRO safety concerns
    • Supervisory training documentation for all supervisors of CDL drivers
    • Drug and Alcohol awareness information provided to all new-hire CDL employees
    • Ensure random testing percentage is attained for calendar year
      • Ensure random pool is updated at least quarterly
    • Prior D & A violation check on all employees hired or transferred into a CDL position
new changes for 2010
New Changes for 2010
  • The DHHS revised the Mandatory Guidelines effective May 2010
  • DOT is expected to implement the DHHS revisions for DOT-regulated testing programs
  • Changes that will impact DOT testing include:
    • Cut-off levels for cocaine and amphetamines are lowered
    • Testing for methamphetamine “designer” analogues (Ecstasy, Adam, Eve)
    • New version of federal CCF
    • Certification of Instrumented Initial Testing Facilities (IITF)--screening only laboratories
program resources from dot
Program Resources from DOT
  • Best Practices for DOT Random Drug and Alcohol Testing
  • Employer Guide to DOT Testing
  • Employee Booklet (What Employees Need To Know About DOT Drug & Alcohol Testing)
  • DOT Specimen Collection Guidelines
    • DOT Collection Checklist
    • Video on Collection Procedures

All of the above are available at www.dot.gov/ost/dapc