DOT Regulations Teleconference

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DOT RegulationsTeleconference

• An Overview for Employers

July 10 - 12, 2001
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Department of Transportation
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DOT and HHS
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Implementation Dates

• January 18, 2001 Amendments to current rule
• Validity testing guidelines
• Adulterated/Substituted MRO Review Split
  Testing
• Public Interest Exclusion (PIE)
• August 1, 2001 Implementation of the full new
  rule

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Employer Responsibility Subpart B, Part
40.11

• Employers are now responsible for compliance with
  the Part 40 requirements.
• DOT and Non-DOT programs must be conducted
  completely separately
• Action required of employers upon receipt of
  verified test results are now detailed in the
  rules.

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Stand DownDefinition

• To remove a donor who has a positive laboratory
  result from duty until the Medical Review Officer
  completes the review.

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Stand DownRule

• Stand-down is prohibited!
• MRO cannot tell employer about laboratory result
  until after verification is completed.
• Rationale Prevent unfair labeling of employee
  as violator before MRO review is complete key
  safeguard.
• Employers may apply for a waiver difficult to
  get

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New Terminology SA

• SA Service Agent is someone other than an
  employer or employee who provides Part 40 drug
  and alcohol services to an employer or an
  employee.
• EHP is a Service Agent

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New TerminologyDER

• DER Designated Employer Representative
• Replaces the term Communicator used by Service
  Agents.

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PIE-NOPE

• Public Interest Exclusion (PIE)
• Purpose is to protect public interest from
  serious noncompliance
• Initiating official issues a Notice of Proposed
  Exclusion (NOPE)
• Employers must stop using service agent within 90
  days of PIE issuance
• Duration 1-5 years

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New Training Requirements

• New rule strengthens training requirements for
  MROs, SAPs, Collectors, BATs, and STTs
• Purpose To reduce the potential for errors and
  to make the process work better for everyone.

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Urine CollectionPolicy Change I

• Major change - Collector training
• Collector training is now required
• Re-training is required after fatal flaw or any
  error that causes a drug test to be cancelled
• Collectors must maintain documentation of their
  training provide it to DOT agency, employers,
  or any service agents who use the collectors
  services.

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Collector TrainingInitial Proficiency
Demonstration

• After Qualification Training
• Demonstration by conducting 5 consecutive
  error-free mock collections
• Must include 2 uneventful 1 insufficient
  quantity 1 temperature out of range and 1
  refusal to sign or initial
• In front of a person who monitors and evaluates
  proficiency

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Collector TrainingError Correction Training

• Required when a Collector makes a mistake which
  causes a test to be cancelled
• Required within 30 days of error notification
• Provided and documented by trainer
• Must address area in which error occurred
• Three consecutive error-free mock collections (1
  uneventful 2 related to error area)

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Urine CollectionPolicy Change II

• Donor must display contents of pocket
• Collector, not donor, transfers urine, closes and
  seals specimen bottle

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Urine CollectionPolicy Change III

• If temperature is outside of normal range the
  collector can no longer take an oral temperature
  or sleeved thermometer temperature.
• An immediate directly observed specimen is
  required.

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Mandatory Direct ObservationCollector Initiated

• Done immediately when temperature out of range or
  any suspicion of tampering
• NO requirement to take body temperature
• NO requirement to seek concurrence from
  supervisor or employer, but must notify afterwards

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Mandatory Direct Observation

• Employer MUST require observed collection if lab
  reports invalid test and MRO states no medical
  reason or if result is positive, adulterated or
  substituted and a requested split specimen is not
  available for analysis.
• Collector MUST require observed collection if
  he/she observes action indicating attempt to
  tamper if temperature out of range or if
  specimen appears to have been tampered with.

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Permissive Direct Observation

• Employer Option to conduct direct observation
  for return-to-duty or follow-up test
• Encourage employers to write letters to DOT about
  the difficulty of this.

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Monitored Collection Procedure I

• NOT a directly observed collection
• Done at employers discretion
• Primarily intended to be used where only a
  multi-stall restroom is available
• Monitors should be same gender unless they are
  medical professionals

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Monitored Collection II

• Monitored collections are not substitutes for
  observed collections
• Sounds or observations indicating an attempt to
  tamper result in observed collection
• Monitor -- who is not collector -- does not
  handle urine specimen

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New CCF

• Labs will begin printing and automatically
  shipping in July
• 5 page format
• CCF 1 Lab Copy
• CCF 2 MRO Copy
• CCF 3 Collector Copy
• CCF 4 Employer Copy
• CCF 5 Donor Copy

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The New CCF

• PRIOR TO to August 1, 2001, employers
• May use new form
• Must use current collection procedures
• AS OF August 1, 2001, employers
• Must use new form
• Must use new procedures
• May not use form for non-DOT tests

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(No Transcript)
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Shy Bladder Procedure

• Urge employee to drink up to 40 oz.
• Refusal to drink is not refusal to test
• Refusal to make an attempt to provide
• Discontinue test
• Contact DER
• 3-hour time limit
• Send CCF copies to MRO employer
• Contact MRO and open a case at EHP for compliance
  with on-going Shy Bladder procedures

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Dilute Specimen

• A negative dilute specimen does not trigger
  direct observation
• Employer may conduct a 2nd collection same
  policy for all employees but can vary by reason
  for test
• If second specimen comes back dilute, it must be
  accepted as a negative
• MUST be included in policy and applied equally
  throughout the company

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Refusal to Test I

• An employee fails
• To appear or remain at site
• To provide urine specimen when required
• To permit directly observed or monitored coll.
• To take a second test as directed
• To provide sufficient urine (w/no med.
  explanation)
• To undergo medical evaluation
• To cooperate with testing process in any way

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Refusal to Test II

• Employer must establish allotted time for the
  person to show up at collection site after being
  sent, include it in company policy, and notify
  collectors
• Collectors notify employer if donor does not
  arrive within allotted time
• May be refusal to test

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Drug Testing Laboratories

• All DOT specimens are inspected for fatal flaws
  and correctable errors
• All specimens are tested for 5 drugs (THC, COC,
  PCP, OPI ,AMP) using HHS cutoffs for initial
  confirmation tests
• All specimens may be subjected to validity
  testing (will be mandatory when HHS defines
  adulteration criteria, certifies labs)

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Fatal Flaws

• Lab inspects each specimen CCF
• Specimen bottle IDs do not match
• Bottle seal is broken or tampered with
• Collectors name and signature omitted
• Insufficient urine
• If found testing process stops
• No longer called Lab Reject
• Lab will report to MRO and MRO will report as
  Test Cancelled (reason)

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Correctable Errors I

• Lab inspects each specimen CCF
• Specimen temperature not checked no remark re.
  outside temperature range
• Collectors signature omitted
• If found document error, testing continues, lab
  attempts to correct
• No longer called Lab Reject
• If not corrected, lab will report to MRO and MRO
  will report as Test cancelled (reason)

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Correctable Errors II

• MRO inspects CCF 2
• Donor signature omitted with no remarks about
  donor refusing to sign
• Certifying scientist signature omitted
• Non-DOT CCF
• If found, MRO attempts to correct. If unable to
  correct, will report as Test cancelled (reason)

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Specimen Validity TestingDilution Substitution

• Voluntary but done by all major labs to some
  degree
• Each specimen must be measured for
• Creatinine
• Specific gravity if creatinine is less than 20
  mg/dL
• pH

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Specimen Validity TestingAdulteration

• Each specimen may be tested for substances that
  may be used to adulterate the specimen
• HHS will define the test requirements
• Specimens suspected of containing an adulterant
  may be sent to another HHS laboratory for
  identification

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Medical Review Officers (MRO)

• Credentials MROs must be licensed MD or DO with
  clinical experience in substance abuse and must
  be certified by MROCC, AAMRO, or ASAM
• For a copy of EHPs MRO credentials for your
  records, e-mail EHPCS_at_EHP.com

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MRO ResponsibilitiesReview Report - Negative
Results

• Review lab report and CCF (w/ employee signature)
• Staff under supervision of MRO may perform this
  administrative function
• Prior to reporting, MRO must have --
• Copy 1 from lab or electronic lab report
• MRO copy (Copy 2), legible copy, or any copy with
  employee signature

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MRO ResponsibilitiesQuality Control - Negative
Results

• MROs must review 5 of negative CCFs per quarter,
  including all of those requiring corrective
  action.
• Reviewed CCFs must be identifiable and
  retrievable for audit.
• EHP is establishing a dedicated DOT fax line for
  results and CCFs 301-841-0463

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MRO ResponsibilitiesContacting Donors -
Non-Negative Results

• Before contacting the DER, the MRO must
• Have copy 1 from lab (faxed copy or image)
• Have MRO copy (Copy 2), legible copy, or any copy
  with employee signature
• Make three attempts to contact donor at varying
  times of day over at least 24 hour period
• Result will remain IN PROCESS until all of the
  above are complete.

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MRO ResponsibilitiesReview Report -
Non-Negative Results

• If contact CAN be made, interview the donor,
  verify and report the result
• If contact CANNOT be made, contact DER

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DER ResponsibilitiesContacting Donors -
Non-Negative Results

• Once contact to the DER is made, the DER takes
  responsibility for contacting the donor.
• DER must
• Try to contact the donor by all means available,
  including certified letters
• If contact is made, direct donor to call the MRO
  and explain the consequences of failing to do so
• Send MRO documentation of contact date and time

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MRO ResponsibilitiesReport Non-Contact
Positive Results

• If CONTACT IS MADE and donor does not call, the
  MRO will report the result as positive in three
  (3) days
• If CONTACT IS NOT MADE, and if DER has exhausted
  all means of contacting the donor, the MRO will
  report as positive after ten (10) days without
  contact.
• 60 Day window for employee to present
  documentation for no contact

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MRO ResponsibilitiesAdulterated/Substituted

• Employee has burden of proof 
• ADULTERATION Must demonstrate adulterant
  entered specimen through physiologic means
• SUBSTITUTION Must demonstrate that he or she
  can produce urine meeting criteria through
  physiological means
• MRO may allow employee up to 5 days to provide
  proof
• MRO must explain split specimen option

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MRO ResponsibilitiesInvalid Result

• Discuss with certifying scientist
• Contact employee for explanation
• If valid medical reason cancel test (no
  re-collection unless negative needed)
• MRO may involve a referral physician,
  acceptable to both MRO and employer, to help
  verify medical explanation
• If no valid medical reason cancel test,
  immediate directly observed re-collection

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MRO ResponsibilitiesRejected for Testing

• Report to DER cancelled test and the reason.
• MRO will direct DER if further action or
  re-collection is required.

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Requests for Split Specimen Test I

• On positive result or refusal to test
  (adulterated/substituted), MRO must explain split
  specimen testing process to employee
• Employee has 72 hours after verification to
  request test of split specimen.

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Requests for Split Specimen Test II

• Employer is required to make sure that MROs and
  laboratories process split specimen tests in a
  timely fashion when requested by donor
• MRO must process split specimen on verbal request
  from donor and payment must be guaranteed by the
  employer however, employer may seek
  reimbursement from donor.

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Alcohol Testing

• Few procedural changes
• Results are reported directly to DER
• Training and certification of BATs parallels new
  training regulation of urine collections

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Substance Abuse ProfessionalSAP Overview

• DOT employers are required to give all employees
  and applicants contact information for a SAP.
• Employer is not required to pay for SAP
  assessment.
• SAP must not make a fitness for duty
  determination return to duty is an employer
  decision.

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Records and Maintenance

• Service Agent
• May receive and maintain for the employer all
  drug alcohol records
• Includes individual test results (negative,
  positive, and refusal to test)
• Information needed to operate a program (e.g.,
  CCFs, ATFs, names in random pools, selection
  lists, and testing notices)
• Service Agent has two days to get the information
  to the employer. Charges may be applicable.

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Record Retention Requirements

• Five years
• Alcohol test results of 0.02 or greater
• Positive drug tests
• Documentation of refusal to test (incl.
  adulterated and substituted test results)
• SAP reports
• Follow-up test results and schedules

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Record Retention Requirements

• Three years
• Records obtained from previous employers
• Two years
• Records of inspection, maintenance, and
  calibration of EBTs
• One year
• Negative and cancelled drug tests, and alcohol
  tests less than 0.02

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Confidentiality andRelease of Information

• Employer or Service Agent prohibited from
  releasing to third parties not specifically
  authorized
• Specific written consent required no blanket
  releases
• MRO must not disclose to 2nd employer (NPRM
  proposal)
• May release in legal proceedings, criminal or
  civil actions

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EMPLOYER RESPONSIBILITIES
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General Responsibilities

• Responsible for all rule requirements
• Responsible for ensuring SA meets all
  qualifications
• For new employees, obtain previous 2 years of
  testing information
• As previous employer, provide 2 years of testing
  information
• with employee written permission

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Quality Control (Blind) Specimens

• 2,000 or more covered employees (applies to both
  employers C/TPAs)
• 1 of specimens (maximum of 50 per quarter)
• Send to all labs used
• 75 negatives
• 15 positive for one or more drugs
• 10 adulterated and/or substituted

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Testing

• Ensure split specimen requests are honored
• Ensure that observed collections take place as
  required
• Separate DOT and non-DOT testing
• Take no personnel action for cancelled tests

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Return-to-duty (RTD) Process

• Provide listing of SAPs at no charge to employee
• No employer requirement to provide SAP evaluation
  or treatment
• No safety-sensitive duties until employee
  completes SAP requirements
• RTD test only after SAPs follow-up report

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Thank you

• For questions contact
• Ehpcs_at_ehp.com