Presented by: Robbie L. Sarles Understanding the Updated USDOT Drug & Alcohol Testing Regulation (49 CFR Part 40) Presented by: Robbie L. Sarles President RLS & Associates, Inc. April 4, 2018 RLS & Associates, Inc. 1

REMEMBER! RLS is NOT is not an official or representative of: United States Department of Transportation (USDOT) USDOT – Office of Drug & Alcohol Policy and Compliance (ODAPC) Any USDOT – Agency (i.e., FTA, FMCSA, FRA, FAA, PHMSA, etc.)

Best Practices NOT Required by USDOT, FTA or Any Other Modal Administration NOT A Regulatory Requirement Addresses Issues That Might Already Be Covered Under Employer’s Own Company/Agency Authority ATTENTION: ANY TEXT WHICH IS BLUE IS MEANT TO INDICATE THAT IT IS NOT A USDOT REQUIREMENT/REGULATION. THESE PROVISIONS WOULD BE BEST-PRACTICES/SUGGESTIONS AND UNDER THE AUTHORITY OF THE EMPLOYER

AGENDA Background Summary of Changes Workplace Impact Questions Additional Resources

Action Items When you see a red star throughout this slideshow – this will indicate to you that there is a potential ACTION ITEM for your attention.

U S D O T Background 49 CFR Part 40 FAA FMCSA USCG FRA PHMSA FTA RLS & Associates, Inc. 12

Background “The What?” “The When?” 49 CFR Part 40 is USDOT’s D&A regulation covering testing procedures Part 40 has been updated “The When?” Jan 2017 – USDOT issued NPRM Nov 2017 – Final Rule published in Federal Register Jan 1, 2018 – Effective Date for all changes

Background “The Who?” Applicable to entire DOT industry (FTA, FMCSA, FRA, FAA, PHMSA, USCG, etc.) ANYONE subject to 49 CFR Part 40 Employers, MROs, SAPs, Collection Sites, etc.

Summary of Changes Drug Testing Panel Modifications “Opiate” changes to “Opioid” Four new opioids added to testing panel Chemical Name Common Brand Names Hydrocodone Norco® ; Vicodin® ; Lortab® Hydromorphone Dilaudid® ; Exalgo® Oxycodone Oxycontin® ; Roxicodone® ; Percocet® Oxymorphone Opana®

Summary of Changes Drug Testing Panel Modifications (continued) “MDA” added to screening test “MDEA” removed Revisions / Updates to Terms & Definitions “DOT, the Department, DOT agency” Modified to encompass all DOT agencies, (FAA, FRA, FMCSA, FTA, PHMSA, NHTSA, OST, and any designee of a DOT agency) Clarified USCG’s relationship with USDOT

Summary of Changes Revisions / Updates to Definitions (continued) “Drugs” – modified to match the additions and revisions as discussed earlier “Alcohol Screening Device” & “Evidential Breath Testing Device (EBT)” List of approved devices now listed on ODAPC’s website (instead of in the federal register) “Substance Abuse Professional” List of qualified agencies for drug and alcohol counselor licenses/certificates will now be listed on ODAPC’s website

Summary of Changes ODAPC List-Serve All service agents REQUIRED to “subscribe” Sign-up via https://www.transportation.gov/odapc/get-odapc-email-updates Prohibition of Use of Federal Branding, etc. Blind Specimen Testing No Longer Required

Summary of Changes Urine Collection / Testing Urine only allowable specimen (no blood, hair, sweat, etc.) No DNA testing allowed 3 new “Fatal Flaws” No CCF with urine specimen at Lab No urine specimen with CCF at Lab Only if a specimen was actually collected Two separate collections on only one CCF

Summary of Changes Urine Collection / Testing (continued) Insufficient “Questionable Specimens” - Always discard & remark New CCF Changes Removed “DOT” box in Step 1D Revised list of drugs in Step 5A

Summary of Changes Urine Collection / Testing (continued) Use of “old” / “new” CCF “New” CCF authorized for use Jan 1, 2018 Continued use of old CCF authorized through June 30, 2018 No ‘memorandum for the record required’ through June 30, 2018 for use of “old” CCF “New” CCF MUST BE utilized July 1, 2018

Summary of Changes MRO Verification Process Clarification of the term “prescription” Prescription (Rx) must be consistent with Controlled Substances Act (CSA) MRO-ordered additional testing Authorized without prior ODAPC consent Meth false positives due to Rx/OTC meds Illicit THC vs. Marinol

Summary of Changes MRO Rx Verification Process MRO release of information – Medically unqualified / Significant safety risk Step 1 – Verify test result Step 2 - Initial MRO determination MRO notifies employee of medically unqualified / significant safety risk Step 3 - Five-days for prescribing physician to contact MRO Employee facilitates contact

Summary of Changes MRO Rx Verification Process (continued) MRO release of information – Medically unqualified / Significant safety risk (continued) Step 4 – Prescribing physician statement to MRO Step 5 – Possible employer notification Based on outcome of Steps 1 - 4

Summary of Changes Other Minor Misc. Changes Removal of outdated compliance dates Minor editorial corrections Update/revisions to weblinks Revisions to Appendix items

Workplace Impact Policy Revisions – Change “opiate” to “opioid” Remove (or edit) “breakdown” of 5-panel drug sub-categories Remove (or edit) drug cut-off levels Revise your “definitions” (if applicable) ASD, EBT, SAP, DRUGS, USDOT

Workplace Impact Policy Revisions – BEST PRACTICES (NOT REQUIRED BY USDOT) If your policy currently has a section on Rx/OTC medication use Update to address MRO determinations of “Medically Unqualified / Significant Safety Risk” If your policy DOES NOT have a Rx/OTC medication use section Consider adding a short paragraph

Workplace Impact OTHER BEST PRACTICES (NOT REQUIRED BY USDOT) (continued) Service Agent education Summary of Regulatory changes Make sure they have a copy of the revised regulation Give them the link on how to sign-up for ODAPC’s List Serve Require evidence that they actually signed up for ODAPC’s List-Serve

Workplace Impact “Medically Unqualified / Significant Safety Risk” Final word is the MRO’s DISCRETION What are the REAL implications? Access to prescribing physician Expiration of Rx No recent contact to prescribing physician What to do when/if you get the phone call This is 100% employer’s determination (No USDOT regulation) Unless USDOT - CDL medical standards apply

Workplace Impact “Medically Unqualified / Significant Safety Risk” Employers should be pro-active in creating a “Fitness-for-duty/Wellness” policy (NOT A USDOT REGULATION) Legal/Union/Collective Bargaining Concerns

Implications MRO Approach To Decision Making Process Is Not Defined In the Regulation MRO discretion based on medical judgement ODPAC Guidance Forthcoming MRO philosophy, assessment of liability and risk management practices will influence approach Case-by-case determination

Implications Possible MRO Determinations Silent—No safety risk, no employer knowledge, no employer action Notification of safety issue—Employer action Follow procedure for CDL standard violation if appropriate Liability Considerations Human Resource Legal Considerations Collective Bargaining

Best Practice Proactively Discuss Philosophy and Procedures with MRO If MRO Philosophy Is Inconsistent with Employer Philosophy or Intent of Regulation, Identify New MRO If MRO Is Unwilling or Unable to Perform This Function, Identify New MRO Define MRO Safety Issue Notification Procedures, Documentation and Timeline Negotiate Cost of MRO Safety Assessment

Implications Employee Facilitation of Prescribing Physician/MRO Contact Employees May Have Difficulty Accessing the Prescribing Physician In a Timely Manner If More Than 5 Days Are Needed To Obtain an Appointment or Otherwise Get In Contact The Prescribing Physician Is Unaware or Does Not Understand the Importance of the Contact Employee Has Had No Recent Contact or Ongoing Relationship with the Prescribing Physician Employee Does Not Know How to Facilitate the Contact Between the Physician and the MRO

Best Practice Assist Employees In Being Proactive Educate Employees on Safety Risks of Rx Provide A Summary of Regulatory Changes ODAPC Notice Review New/Revised Employer Policy Define Process and Provide Guidance On How to Notify Prescribing Physician to Contact MRO

Best Practice Encourage Employees to Obtain Updated Rx Current Rx Is More Than One Year Old Rx States “Take As Needed” For An Injury That Is No Longer Being Treated By the Prescribing Physician Employee Does Not Have an Ongoing Relationship with the Prescribing Physician ER/Urgent Care or Doc-in-a-Box Physicians

Best Practice Encourage Employees to Obtain Updated Rx (cont.) Revisit Treatment Options With Prescribing Physician for Chronic or Reoccurring Conditions To Minimize Safety Impacts While Not Compromising Medical Care Encourage Employees Using Opioids to Discuss Dosing Option with Prescribing Physician Timing Dosage Alternative Pain Management Options

Best Practices Provide Employees with a Physician Rx Medical Authorization Form Job Description Highlighting Safety-Sensitive Duties Area for Prescribing Physician to Indicate Possible Safety Risks With Corresponding Restrictions, If Any Notification that Prescribing Physician May Be Contacted By MRO If A Safety Concern Exists

Best Practices Inform Applicants of Possible Prescribing Physician/MRO Contact Requirement Provide Explicit Directions As Early on In the Hiring Process As Possible Emphasize That a Valid Rx Does Not Necessarily Mean Disqualification. Rx Is Only An Issue When It Rises to the Level of Safety Risk.

Implications Employer’s Response Not Defined Assessment of Nature and Scope of Safety Risk Short-term, Long-term, Permanent Course of Action/Remedy Monitoring Process and Revaluation Medical Advisory and Decision Making Process Employee Consequences And Due Process Documentation, Record-keeping, and Confidentiality Liability and Risk Management

Employer Challenge Best Practice Is to Develop An Effective Rx Fitness-for-Duty Program A program that minimizes the associated impairment risks of taking legally and illegally obtained prescription medications while performing transit–related, safety-sensitive functions

Best Practice Establish a Fitness-for-Duty Program Policy Consequences Medical Review of Employees Deemed to be a Safety Risk Procedures Employee Education Documentation, Reporting, Confidentiality

Questions?

Resources USDOT - ODAPC Resources Final Rule: https://www.gpo.gov/fdsys/pkg/FR-2017-11-13/pdf/2017-24397.pdf Brief summary of changes: https://www.transportation.gov/odapc/Part_40_Final_Rule_Summary_of_Changes CCF Notice: https://www.transportation.gov/odapc/Notice_CCF_December_2017 Policy Notice: https://www.transportation.gov/odapc/Part_40_DOT_Policies_Notice_2017 Employee Notice: https://www.transportation.gov/odapc/Part_40_DOT_Employee_Notice_2017

Resources Other Resources National RTAP Recorded Webinar (Part 40 Update): http://www.nationalrtap.org/Webinars#DrugAlcoholUpdate National RTAP Recorded Webinar (Fitness For Duty): http://www.nationalrtap.org/Webinars#fitnessforduty A more in-depth look at key factors in developing a fitness-for-duty policy