Drug and Alcohol Testing Programs Updates for FTA-regulated Employers

1. Drug and Alcohol Testing ProgramsUpdates for FTA-regulated Employers Dr. Donna Smith FirstLab, Inc. dsmith@firstlab.com February 2009

2. August 2008 Recent Part 40 revisions

3. 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

4. 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

5. 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

6. 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

7. Direct Observation Collections • 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 • 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 chest 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

8. 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

9. Resources from DOT’s Office of Drug & Alcohol Policy & Compliance • 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 All of the above are available at www.dot.gov/ost/dapc

10. Designated employer representative (DER)Duties, program components, best practices

11. Designated Employer Representative (DER) • Serves as point of contact for the testing program • Receives test results from the Medical Review Officer and Breath Alcohol Technician (BAT) • Ensures that employees who violate the policy are removed from safety-sensitive duties and meet return to duty requirements, if they return to work • Ensures that all eligible employees are in a random testing pool • Serves as the custodian for all records required by the DOT rules

12. Reasonable Suspicion Training • Required for all supervisors • Minimum of 2 hours • Signs and symptoms of drug/alcohol misuse • Criteria for reasonable suspicion testing • Procedures for documenting R/S testing and getting employee tested • Training can be classroom, video, computer-based

13. Employee Drug and Alcohol Awareness Information • Educational materials or training classes should be provided to all employees subject to testing • Information should include: • Prohibited conduct • Testing requirements and procedures • Consequences and disciplinary actions • Employee rights and responsibilities in testing program • Alcohol and drug abuse awareness information • Information on getting help with a substance abuse problem • Employee should sign acknowledgment of receipt of information/materials

14. Hiring or Transferring to a DOT Position • Pre-employment/post-offer testing with a negative result before person is hired or transferred • Employee put in random pool immediately after hiring/transfer • Prior employer Drug and Alcohol violations check • Documentation that question concerning a previous positive or refusal to test on a DOT pre-employment test is asked on application or at time of offer

15. Reasonable Suspicion Testing • Based on the observations of a supervisor who has completed R/S training • Supervisor’s observations must be documented on a form or written report • R/S tests must be completed ASAP after decision to test is made • If both alcohol and drug tests are indicated, the alcohol test should be conducted first • Employee should be escorted to testing site • Employee should not be permitted to return to work after testing; transportation home should be offered • RTW only after test results are received

16. Post-Accident Testing • Understanding of FTA criteria for post-accident testing • FTA created a quick reference guide that provides information on FTA post-accident thresholds, who should be tested and limitations for testing.The 3 x 2 laminated cards can be ordered on-line from the Publications tab of the FTA, Office of Safety and Security website • Records for DOT post-accident and non-DOT or company authority post-accident testing must be separate and distinct • Thorough documentation of all DOT post-accident testing incidents • Time constraints for accomplishing testing • Procedures in place for accomplishing post-accident testing during “non-business” hours

17. RANDOM TESTING • Ensure all eligible employees are in testing pool and that pool is updated as needed • Random selection process meets DOT requirements • Documentation of reasons why selected employees are not tested • Tracking to ensure that minimum percentage is achieved • Tracking to ensure that there is no predictable pattern to when random tests are conducted • Remember that cancelled random tests do not count toward required annual percentage

18. Random Testing Basics • Updating of pool • Safety-sensitive employees should be placed in pool immediately upon hire or transfer into position • Pool should be reviewed and made current before each random selection is made • Random selections must be made at least quarterly and both the selection dates and the testing dates should be unpredictable and shown no identifiable pattern • Each eligible employee must have an equal chance of being selected and of being tested • Use of “alternates” is discouraged; use “over selection” criteria instead • Alternates can only be tested if all “primary” selectees have either been tested or are not available for the entire testing cycle • Once notified of selection for testing, employee must proceed immediately to testing site

19. Random Testing Best Practices • Random testing dates must demonstrate an unpredictable pattern and be reasonably applied to all shifts or work cycles • If DER selects random testing dates, selected employees who are absent or otherwise not available on the selected date are not “excused” from testing for the selection period • Once a new random selection is made, employees selected for the previous period cannot be tested • Random alcohol testing is limited to just before, during or just after performing safety-sensitive duties

20. Return to Duty and Follow-up Testing • Occur only when there has been a DOT violation (positive, refusal to test, etc.) • RTD test conducted after SAP has provided follow-up evaluation report stating that employee has complied with treatment requirements • Follow-up testing determined by SAP • Begins when employee returns to safety-sensitive duties • Minimum of 6 FU tests in first 12 months after return to duty • FU testing may extend for up to 60 months as ordered by SAP • Number of tests and duration of testing determined by SAP • Employer sets schedule for “no notice” FU tests • Employee is also in random pool

21. MRO Drug Test Results • Negative—No drugs present above cut-off level • Negative Dilute—No drugs present above cut-off level and low specific gravity & creatinine • Positive—Drugs present and no medical explanation • Refusal to Test—Adulterated (contains exogenous substance or excessive level of endogenous substances) or Substituted (SG & creatinine not consistent with human urine)—or no medical explanation for inability to provide a urine specimen • Canceled Test—Invalid specimen, flawed collection/specimen, Shy bladder with medical explanation

22. Alcohol Test Results • Reported to you by the BAT if result is above 0.020 BrAC • May be reported directly to your TPA if result is less than 0.020 • A result less than 0.020 is a Negative • 0.020-0.039 result requires temporary removal from duty but is not a positive • 0.040 or greater is a positive alcohol test—a violation of DOT rules

23. EAP & RETURN TO DUTY • Procedures for SAP contact information being provided to employees/applicants • Company policy on EAP , if available • Last chance agreements, return to duty after treatment, etc. • Ensuring employee is returned or continued in random pool, in addition to a follow-up testing program

24. Records • The records shall be maintained in a secure location with controlled access. • §655.71 specifies the records to be maintained and the periods of retention • Types of records to be maintained include records related to: • Collection process • Test results • Referral and return to duty and follow-up testing • Employee training • §40.333 also specifies records employers must keep

25. Documents needed for record maintenance under 40.333 • Keep the following records for five years: • Records of alcohol test results indicating an alcohol concentration of 0.02 or greater; • Records of verified positive drug test results; • Documentation of refusals to take required alcohol and/or drug tests (including substituted or adulterated drug test results); • SAP reports; and • All follow-up tests and schedules for follow-up tests. • Keep records for three years of information obtained from previous employers under §40.25 concerning drug and alcohol test results of employees. • Keep records of the inspection, maintenance, and calibration of EBTs for two years. • Keep records of negative and cancelled drug test results and alcohol test results with a concentration of less than 0.02 for one year.

26. Additional Records Required under Part 655 • Documents relating to the random selection process. • Documents generated in connection with decisions to administer reasonable suspicion drug or alcohol tests. • Documents generated in connection with decisions on post-accident drug and alcohol testing. • MRO documents verifying existence of a medical explanation of the inability of a covered employee to provide an adequate urine or breath sample. • The employer's copy of the custody and control form. • Documents related to the refusal of any covered employee to submit to a test required by this part. • Documents presented by a covered employee to dispute the result of a test administered under this part. • Training materials on drug use awareness and alcohol misuse, including a copy of the employer's policy on prohibited drug use and alcohol misuse. • Names of covered employees attending training on prohibited drug use and alcohol misuse and the dates and times of such training. • Documentation of training provided to supervisors for the purpose of qualifying the supervisors to make a determination concerning the need for drug and alcohol testing based on reasonable suspicion. • Certification that any training conducted under this part complies with the requirements for such training • Copies of annual MIS reports submitted to FTA.

27. Record maintenance—Best Practices • Maintain paper records in secure, controlled access filing cabinet • Drug & alcohol testing records should not be maintained as part of employee personnel file • Filing by date within record type categories is generally most efficient • If records are maintained electronically, including pdf or other images of CCFs, ATFs, etc., they must be capable of being printed/reproduced as paper documents • Records maintained at employer’s principal place of business should not be transferred or transported off-site • Audits by FTA and state oversight agencies are conducted at employer’s place of business • Statistical and data summary reports may be required/requested by oversight agencies for ongoing compliance monitoring

28. Specimen collection processensuring integrity of the testing program

29. Specimen Collection • The DOT, DHHS and other government entities have identified the specimen collection process as the “weak link” in the federal drug testing programs • Program integrity, deterrence and detection of illicit drug use, and ultimately safety, are affected by collection procedures that give opportunities for donors to, adulterate, substitute, and manipulate their urine specimens • The original specimen collection procedures emphasized the proper identification of the specimen with the donor, the security of the specimen through chain of custody documentation, and the donor’s privacy rights. • Products and instructions for “beating a drug test” have become readily available via the internet and other media. • DOT collection procedures have been refined and revised to place more emphasis on preventing cheating on the test

30. Protecting Specimen Integrity • Elements of the specimen collection process designed to deter and detect attempts to adulterate, substitute, dilute or otherwise defraud the drug test • Preparation of the specimen collection site • Deterrent actions with the donor • Specimen integrity checks by the collector

31. Preparation of the Collection Site • Water sources in toilet enclosure are disabled so there is no access to add water to the specimen, mix or prepare solutions, etc. • Bluing placed in toilet bowl, tank lid taped or tank water blued • Access/exits restricted or secured • Cleaning supplies, materials, other possible contaminants removed • Collection supplies discarded/removed • Inspect storage areas or “hidden spaces” for urine specimens, bottles, adulterants, etc. • Post public restroom against unauthorized entry • Prepare one stall for use; collector remains inside restroom

32. Deterrent Actions with Donor • Have donor remove all “outer garments” (jackets, coats, coveralls, hats, etc.) • Require donor to leave all hand carried items outside toilet enclosure (bags, purses, cell phones, IPods, etc.) • Donor may retain only wallet, money clip, money, credit cards, etc.) • Require donor to empty all pockets and display contents • Donor must leave all items from pockets, except money, outside the toilet enclosure • Require donor to wash & dry hands in presence of collector before entering the toilet enclosure • Provide donor with only the collection container—not the specimen bottles to take into the toilet enclosure • Accompany donor to door of toilet enclosure • The collector may set a reasonable time for the donor to remain in the toilet enclosure • Pay close attention to the donor and his actions in this preparation process

33. Specimen Integrity Checks by the Collector • Specimen temperature check • Within 4 min. of the donor presenting the specimen • Acceptable temperature range 90-100°F • If temperature is out of range, a 2nd immediate collection under direct observation must be conducted • Specimen volume check • Must be at least 45 mL in collection container • If less, specimen must be discarded (unless specimen is “suspect”) • Specimen color, odor, physical properties check • If specimen is green/blue or other color inconsistent with voided specimen, specimen is “suspect” • If specimen’s odor yields bleach, ammonia, vinegar or other common adulterant, specimen is suspect • If specimen appears to have visible residue or sediment, is excessively frothy or bubbly, specimen is suspect

34. Additional Deterrent Actions • Donor is not permitted to leave collection site “control” at any time during collection process • Including while waiting because of a “shy bladder” or waiting for a second observed collection • Collector must keep specimen under his/her control and sight at all times after presentation by the donor • Closely monitor and control access to fluids during shy bladder procedure and at any time while donor is waiting to provide specimen • Decrease time donor is kept waiting after “signing in” and beginning collection process

35. Additional Specimen Integrity Measures • Direct Observation collection procedures required when: • Collector believes donor brought item(s) to collection site intended to defraud test or impact specimen integrity • Specimen temperature is out-of-range • Specimen color, odor, physical appearance is unusual • MRO has ordered a direct observation because previous test was: • Cancelled-Invalid (no medical explanation) • Cancelled because there was no split available • Dilute with Cr. 2-5 • Direct Observation procedures modified to include inspection of donor for adulterant/substitution apparatus • Donor must adjust clothing so that observer can view the donor’s body (front and back) from chest to mid-thigh to inspect for adulteration/substitution paraphernalia • Donor may reposition clothing after the visual inspection and proceed to provide specimen in observer’s presence

36. DOT’s 10 Steps to Collection Site Security and Integrity Office of Drug and Alcohol Policy and Compliance • 1. Pay careful attention to employees throughout the collection process. • 2. Ensure that there is no unauthorized access into the collection areas and that undetected access (e.g., through a door not in view) is not possible. • 3. Make sure that employees show proper picture ID. • 4. Make sure employees empty pockets; remove outer garments (e.g., coveralls, jacket, coat, hat); leave briefcases, purses, and bags behind; and wash their hands. • 5. Maintain personal control of the specimen and CCF at all times during the collection. • 6. Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets, secure tank lids). • 7. Ensure that the water in the toilet and tank (if applicable) has bluing (coloring) agent in it. Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank. • 8. Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present. • 9. Inspect the site to ensure that no foreign or unauthorized substances are present. • 10. Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas, ceiling tiles) that appear suitable for concealing contaminants.

38. Employer Responsibilities • Ensure all collectors meet DOT training qualification standards • Request that “DOT’s 10 Steps to Collection Site Security and Integrity “ posters be displayed at collection sites • Available on ODAPC website www.dot.gov/ost/dapc • Encourage the use of a collector checklist for each collection • Ensure that collection sites are aware of direct observation procedures and conduct same as required • Review employer copies of CCFs to ensure they are complete and accurate • Visit collection sites frequently; conduct audits or administer questionnaires to reinforce use of correct specimen collection procedures

40. Prescription & OTC Medications implications for safety & performance

41. Legal vs. Illegal Drugs • NTSB, ONDCP, SAMHSA and other government agency studies indicate that abuse and misuse of prescription controlled substance medications is more prevalent than “illicit” drug use. • Dramatic increase in past decade in use of medications for chronic pain, anxiety, sleep disorders, & attention deficit disorders. • Inappropriate use of medications takes several forms: • Non-medical use • Misuse • Abuse • Physiological dependence • Psychological dependence

42. Inappropriate Use-Definitions • Non-medical use is when use of the medication is not prescribed by a medical professional and is used for the experience or feeling it causes. • Misuse is the incorrect use of a medication by not following prescribed dosage levels, frequency of use, or use for a purpose other than for which it was prescribed. • Abuse is when the pattern of use leads to clinically significant impairment or distress that manifests itself in the individual’s behavior. • Physiological dependence is when the individual experiences increasing tolerance for a drug and experiences withdrawal when the medication is discontinued. • Psychological dependence or addiction is when the individual experiences an overall loss of control, seeks medication compulsively, and continues use of the medication in spite of negative consequences.

43. DOT Drug Testing Limitations • DOT drug testing is limited by OTETA to Schedule I & II drug classes • Most painkillers, anxiety drugs, sleep aids, etc. are Schedule III, IV & V drugs • Largest class of painkillers, synthetic opioids, are not detected in DOT testing: • Oxycodone, hydrocodone, hydromorphone, oxymorphone, methadone • Benzodiazepines, barbiturates, and propoxyphene are also not detected in DOT testing • Urine drug test does not indicate impairment, nor can it determine abuse or misuse of prescribed medications

44. NTSB Directives to FTA • Educate transit systems - Potential safety risks of Rx and OTC • 2002 publication of FTA’s Prescription & OTC Medication Tool Kit • Require notification of Rx/OTC use by safety-sensitive employees • Incorporate qualified medical personnel in Fitness for Duty Assessment • Train employees on roles and responsibilities • FTA should establish a comprehensive toxicological testing requirement for a sample of fatal transit accidents to identify the role played by common Rx/OTC medications • FTA is undertaking a study to assess the current status of Rx/OTC policies within the transit industry and to determine the extent to which transit systems collect and maintain data regarding the role Rx/OTC medications play in fatal accidents. All transit systems were asked to complete online questionnaires by Jan 30, 2009

45. MRO Safety Concern on DOT Drug Test • Issued by MRO when laboratory positive drug test is due to use of a prescribed or medically administered drug and MRO believes: • Use of prescribed medication poses a significant safety risk, or • Medical condition for which medication is prescribed may pose a significant safety risk • Test result will be reported as “Negative” with MRO comment of a safety concern • Employee is informed by MRO that safety concern is being reported to employer

46. MRO Notice to Donor • MRO notifies donor that he/she can submit (within 5 days) documentation from prescribing physician that demonstrates: • Medication has been discontinued, or • changed to one that does not cause concern • If MRO receives such documentation, employer will be notified that safety concern is removed

47. MRO Safety Concern Notification • The medical review officer is required by 49CFR Part 40.327 to provide to third parties, drug test results and medical information affecting the performance of safety-sensitive duties which are obtained during the verification process. • Employee •  Social Security or ID •  Date of Specimen Collection •  Date of MRO determination •  As a result of the MRO verification process, the MRO has determined that in addition to the drug test result there is a: • Safety Concern – Medication –Employee has reported the use of medication(s) that may pose significant safety risk or may make the employee medically unqualified for a safety-sensitive position. • In accordance with §40.135 (c) the employee has been notified that they have 5 days for the prescribing physician to contact the MRO to determine if the medication can be changed to one that does not make the employee medically unqualified or does not pose a significant safety risk. Employer will be notified if this information is provided. If you do not receive an amended report, additional information that the medication was discontinued or changed was not provided • Additional information obtained from the treating provider on , that medication of concern has been discontinued or changed to one that does not present a safety concern • Additional information obtained from the treating provider on , that medication of concern has been changed, but to one that also presents a safety concern • Safety Concern – Medical Condition – Employee has disclosed a medical condition that may have an adverse impact on the safe performance of safety-sensitive duties--Recommend evaluation by Occupational Health professional • Safety Concern – Medical Condition – Employee has disclosed a medical condition that may result in the employee not meeting Federal medical standards - Recommend evaluation by Occupational Health professional/Medical Examiner. • Medical Review Officer Name: _________________________________________ • Medical Review Officer Signature: _________________________________________ • Date: _________________________________________

48. Employer Actions on MRO Safety Concern • Options for resolving safety-concerns • Have prescribing physician provide statement that employee is able to perform safety-sensitive duties while taking medications • Have employee undergo “fitness for duty” evaluation by employer designated physician • Important for transit employer to have medication policy and procedures in place • MRO cannot make “fitness for duty” recommendation based on donor interview and urine drug test result

49. Medication Safety Issues • Possible “impairing” effects • Risks associated with medical conditions for which meds are being used • Interactions with other medications and OTC products • Compliance with recommended dosing • Dosage amounts • Timing of taking meds • Therapeutic course; acute vs. chronic • Employee lack of awareness of impairing effects

50. Somnolence Fatigue Impaired judgment Hypotension Sedation Erratic performance Impaired reflexes Dyskinesias and other neurologic dysfunction Headaches Muscle weakness Visual disturbance Medication Use Side effects of concern