Drug Testing in the Workplace

1. Drug Testing in the Workplace Presented by Dr. Ramesh Certified Medical Review Officer Alliance Occupational Medicine

2. Substance Abuse in the News The largest oil spill in over 2 decades in the San Francisco Bay occurred due to substance abuse by the pilot, Capt. John Cota, of a cargo ship. The Cosco Busan's collision with a Bay Bridge tower in 2007 tore a 211-foot gash in the Hong Kong cargo ship, spilling bunker fuel. The Cosco Busan spill oiled 69 miles of shore, closed fisheries and killed more than 2,500 birds. The NTSB concluded it was caused by Cota's "degraded cognitive performance from his use of impairing prescription medications.“ The National Transportation Safety Board found that Cota had a drunken driving conviction, a history of alcohol abuse and prescriptions for at least nine medications, including Valium; Vicodin; Zoloft for depression; Ativan, an anti-anxiety drug; Provigil for sleep disorders; Imitrex for migraines; and Darvon for pain.

3. Substance Abuse In the News The accident was the largest oil spill in the bay since 1988. The Cosco Busan's owner, Regal Stone Ltd., and its operator, Fleet Management Ltd., both of Hong Kong, agreed to pay $44 million to settle the civil case. Capt. John Coto is currently trying to get his Mariner’s license back, however, the Coast Guard found that Cota "did not meet the medical standards and the professional qualifications requirements for renewal." They issued a final denial in Feb. 2012.

4. Agenda • Substance Abuse Statistics • What is Reasonable Suspicion? • Signs and Symptoms of Substance Abuse • Components of a Drug Free Workplace Program • Specimen Testing and Confirmation • MRO Role in DOT Testing • Differences in DOT and non-DOT Testing • Alcohol Testing • Alternative Testing • Case Studies

5. Substance Abuse Statistics Prevalence of Illegal Drug Use • Percent of persons 12 years of age and over with any illicit drug use in the past month: 8.7% (2009) and 8.9% (2010) • Percent of persons 12 years of age and over with marijuana use in the past month: 6.6% (2009) and 6.9% (2010) • Percent of persons 12 years of age and over with any non-medical use of a psychotherapeutic drug in the past month: 2.8% (2009) and 2.7% (2010) Source: CDC

6. Substance Abuse Statistics Results from the 2010 National Survey on Drug Use and Health Summary of Findings: • 2010, Marijuana was the most commonly use illicit drug with 17.4 million current users. Past month illicit drug use among persons aged 12 or older

7. Substance Abuse Statistics Past Month Use of Selected Illicit Drugs among Persons Aged 12 or Older: 2002-2010

8. Substance Abuse Statistics Past month illicit drug use among persons aged 12 or older by age: 2009 and 2010

9. Substance Abuse Statistics Alcohol Use Among Person Aged 12 or Older • Slightly more than half of Americans aged 12 or older reported being current drinkers of alcohol in the 2010 survey (51.8%). This translates to an estimated 131.3 million people, similar to 2009, 130.6 million (51.4%) • Nearly one quarter (23.1%) of persons aged 12 or older participated in binge drinking at least once in the 30 days prior to the survey in 2010. This translates to 58.6 million people, similar to 2009 (23.7%) • 2010, heavy drinking was reported by 6.7% of the population aged 12 or older or 16.9 million people, similar to 2009 (6.8%) Definitions: Current Use (past month) –at least 1 drink in the past 30 days Binge Use- > 5 drinks on the same occasion on at least 1 day in the past 30 days Heavy Use - > 5 drinks on the same occasion on each of 5 or more days in the past 30 days.

10. Substance Abuse Statistics Current binge and heavy alcohol use among person aged 12 or older by age: 2010

11. Substance Abuse Statistics Driving under the influence of alcohol in the past year among persons aged 12 or older: 2002-2010

12. Substance Abuse Statistics Driving under the influence of alcohol in the past year among persons aged 16 or older: Grouped By age: 2010

13. What is Reasonable Suspicion? Must be base on a reasonable belief that the employee is under the influence of alcohol or drugs on the basis of specific observations concerning the employee’s: • Appearance • Behavior • Speech • Body odor After Before

14. What is Reasonable Suspicion? EXAMPLES: Worsening of Personal Appearance • dress, speech, gait, body odor Decreased Reliability • absences, late, sick leave, missed deadlines, etc. Loss of Problem Solving • Ignores problems, covers up, blames others, etc. Decrease in Job Knowledge • Reduced skills, needs supervisor, slow learning, etc.

15. What is Reasonable Suspicion? EXAMPLES (cont.): Decrease in Productivity • many breaks, wastes time, does not complete tasks Poor Judgment • bad decisions, tactless, illogical behavior, etc. Difficulty Working with Others • poor listening and communication skills, hostile, argumentative, etc.

16. Odor of alcohol Odor of marijuana Slurred speech Flushed swollen face Red or runny eyes or nose Pupils dilated or constricted or unusual eye movements Lack of coordination Tremors, sweats Exhaustion, fatigue Sleepiness Nausea Reduced concentration/focusing Unauthorized possession of alcohol or illegal drugs Any other suspicious behavior Signs and Symptoms of Substance Abuse

17. Components of a Drug Free Work Place Program Issued by President Regan in 1986: • Written policy regarding substance abuse • Supervisor training • Employee education • Employee Assistance Program • Methods for identifying drug users (drug testing)

18. Components of a Drug Free Work Place Program Purpose of Drug Testing: • Reduce illicit/inappropriate use of drugs among workers • Educate workforce managers and employees • Identify and remove drug users from safety sensitive jobs • Treat and rehabilitate drug abusers • Create a deterrent against drug use/abuse

19. Components of a Drug Free Work Place Program Types of Drug Testing: • Pre-employment • Post accident • Reasonable suspicion/for cause • Random • Return to duty • Follow up to treatment • Periodic/voluntary

20. Standards of Practice: Federally regulated - DHHS - DOT - DOD Non federally regulated State laws Workers compensation Union Contracts Components of a Drug Free Work Place Program

21. Components of a Drug Free Work Place Program Drug Testing – 3 Steps • Specimen Collection • Specimen Testing and Confirmation • Medical Review of Results (MRO) Test for: - Illicit drugs (urine) - Alcohol (breath, saliva) - Other specimens (oral, fluids, hair)

22. Components of a Drug Free Work Place Program DOT Urine Specimen Collection Procedures • The collector will ask the donor for photo identification • After verification of the donor’s identification, the collector will complete Step 1 of the Custody and Control Form (CCF) • The collector will ask the donor to remove any unnecessary outer clothing (coat, jacket, hat, etc.) and to leave hand carried items (i.e. briefcase, pocketbook bags, etc.) outside the toilet enclosure. The collector will secure these items and provide a receipt if requested by the donor. The donor may retain his/her wallet, money clip etc.

23. Components of a Drug Free Work Place Program DOT Urine Specimen Collection Procedures (cont.) • The collector will direct the donor to empty his/her pockets and display the contents. Any items which can be used to adulterate or substitute the specimen must be left outside the toilet enclosure. If the collector believes that any items were brought specifically with the intent to adulterate or substitute the specimen, the collector shall conduct the collection under direct observation. • The collector will instruct the donor to wash and dry his/her hands. • The collector will provide the donor a wrapped/sealed collection container and specimen bottle (s). Either the collector or the donor may open the container/bottle (s) in the donor’s presence.

24. Components of a Drug Free Work Place Program DOT Urine Specimen Collection Procedures (cont.) • The collection container and the specimen bottles must be separately wrapped. Only the collection container should be taken into the toilet enclosure. The wrapped bottles should remain outside the enclosure and be opened in the donor’s presence when the donor presents the filled collection container to the collector. • The collector will accompany the donor to the toilet enclosure where the donor will provide the urine specimen. The donor will enter the toilet enclosure and shut the door, the collector remains outside the close door. • The donor will hand the filled collection container to the collector. Both the donor and the collector should maintain visual contact of the specimen until the labels/seals are placed over the bottle cap(s).

25. Components of a Drug Free Work Place Program DOT Urine Specimen Collection Procedures (cont.) • The collector checks the specimen, reading the specimen temperature indicator within 4 minutes of receiving the specimen from the donor. The collector marks the appropriate box in Step 2 of the CCF. If the specimen temperature is outside the acceptable temperature range (90-100° F), the collector must direct the donor to provide another specimen under direct observation. The out-of-temperature-range specimen is not discarded. • The collector checks the specimen volume, ensuring that there is at least 45 ml. of urine. If the employee is unable to void or voids an insufficient amount of urine, the employee will be provided up to 40 oz. of fluids and up to three hours to provide the specimen. Any partial specimen will be discarded.

26. Components of a Drug Free Work Place Program DOT Urine Specimen Collection Procedures (cont.) • The collector checks the specimen for unusual color, odor, or other physical qualities that may indicate an attempt to adulterate the specimen. If present, the collector must direct the donor to provide another specimen under direct observation. • The collector will pour at least 30 ml of specimen into a specimen bottle (Bottle A). The remainder of the specimen (at least 15 ml) will be poured into a second bottle (Bottle B) • The collector immediately places the lid/cap (s) on the specimen bottles, and then applies tamper-evident label/seals (CCF, Step 3). • The collector will write the date on the label/seals. The donor will be asked to initial the label/seal (s) once they are affixed to the bottles.

27. Components of a Drug Free Work Place Program DOT Urine Specimen Collection Procedures (cont.) • After sealing the specimen bottles, the donor will be permitted to wash and dry his/her hands, if he/she do desires. • The donor will be instructed to read and complete the donor certification section of the CCS (Step 5), including signing the certification statement. • The collector will complete the chain of custody section of the CCF (Step 4), including signing the certification statement, recording the date and time of the collection, and entering the name of the Delivery or courier service (e.g. FedEx, DHL, USPS, LabCorp Courier). • The collector will record any remarks concerning the collection process in the “remarks” in Step 2 of the CCF.

28. Components of a Drug Free Work Place Program DOT Urine Specimen Collection Procedures (cont.) • The collector will place the sealed specimen bottles and Copy 1 of the CCF into the polyurethane bag and seal it. If the specimens are being transported by express or common carrier, the bag is placed in a hard-sided shipping container. • The collector will give the donor his/her copy of the CCF (copy 5). The donor may leave the collection site at the completion of this step of the collection process. • The collector will distribute the remaining copies of the custody and control form. Copy 2 should be faxed to the MRO listed in Step 1 of the CCF. Copy 3 is retained by the collector for 30 days. Copy 4 is faxed to the Designated Employer Representative (DER) listed in Step 1 of the CCF. If Copy 2 & 4 are not faxed to the MRO and DER respectively, they must be mailed or send within 24 hours or the next business day of the collection.

29. Components of a Drug Free Work Place Program DOT’s Direct Observation Procedures • DOT’s 49 CFR Part 40 directly observed collections are authorized and required when: • The employee attempts to tamper with his or her specimen at the collection site. • The specimen temperature is outside the acceptable range. • The specimen shows signs of tampering  unusual color/odor/characteristic • The collector finds an item in the employee’s pockets or wallet which appears to be brought into the site to contaminate a specimen: or the collector notes conduct suggesting tampering

30. Components of a Drug Free Work Place Program DOT’s Direct Observation Procedures (cont.) • The Medical Review Officer (MRO) orders the direct observation because: • The employee has legitimate medical reason for certain atypical laboratory results or • The employee’s positive pr refusal (adulterated/substituted) test result had to be cancelled because the split specimen test could not be performed (for example, the split specimen was not collected). • The test is a Follow-Up test or a Return-to-Duty test.

31. Components of a Drug Free Work Place Program DOT’s Direct Observation Procedures (cont.) • The observer must be the same gender as the employee. • If the collector is not the observer, the collector must instruct the observer about the procedures for checking the employee for prosthetic or other devices designed to carry “clean” urine and urine substitutes AND for watching the employee urinate into the collection container. • The observer requests the employee to raiser his or her shirt, blouse or dress/skirt, as appropriate, above the waist, just above the navel, and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device.

32. Components of a Drug Free Work Place Program DOT’s Direct Observation Procedures (cont.) • The observer requests the employee to raiser his or her shirt, blouse or dress/skirt, as appropriate, above the waist, just above the navel, and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device. • If the Employee Has a Device: The observer immediately notifies the collector; the collector stops the collection; and the collector thoroughly documents the circumstances surrounding the event in the remarks section of CCF. The collector notifies the DER. This is a refusal to test. • If the Employee Does Not Have a Device: The employee is permitted to return clothing to its proper position for the observed collection. The observer must watch the urine go from the employee’s body into the collection container. The observer must watch as the employee takes the specimen to the collector. The collector then completes the collection process.

33. Components of a Drug Free Work Place Program DOT’s Direct Observation Procedures (cont.) 4. Failure of the employee to permit any part of the direct observation procedure is a refusal to test.

34. Specimen Testing and Confirmation Goals of a Forensic Drug Testing Laboratory • To discriminate reliably between those specimens which contain drugs or its metabolite at or above the cut off and those which do not. • To determine specimen validity. • To identify specimens that are substituted or adulterated • To perform these tests in a legally defensible manner.

35. Specimen Testing and Confirmation Initial Test (Screening Test) • Immuno assay test which meets the FAD requirement Negative Specimen • Any specimen whose apparent concentration of drug or metabolite is less than the pre-established cut-off concentration fore that drug or metabolite. • Not necessarily a specimen containing no drug or metabolite.

36. Specimen Testing and Confirmation Positive Specimen • Any specimen whose apparent concentration of drug or metabolite is greater than or equal to the pre-established cut-off concentration for that drug or metabolite What is a Cut-Off? • An arbitrary point on a continuum of possible drug or metabolite concentrations. • Use to divide specimens into negatives and positives

37. Specimen Testing and Confirmation HHS Mandated Screening Cut-offs (ng/ml) • Marijuana Metabolites 50 • Cocaine Metabolites 150 • Opiate Metabolites 2000 • PCP 25 • Amphetamines 500

38. Specimen Testing and Confirmation Confirmatory Test • A second analytical procedure performed on a different aliquot of the original specimen to identify an agent or the presence of a specific drug or metabolite. • Combination of gas chromatography and mass spectrometric analysis GC/MS.

39. Specimen Testing and Confirmation DOT Mandatory Confirmation Cut-offs (ng/ml) • Marijuana Metabolites 15 • Cocaine Metabolites 100 • Opiate Metabolites 2000 • PCP 25 • Amphetamines 250

40. Specimen Testing and Confirmation Validity Testing • Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine. • The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the urine, if the urine was diluted, or if the specimen was substituted.

41. Broad MRO Role In DOT Testing • MRO is the “gatekeeper” of testing process. • Responsible for review of custody and control form for errors (negatives & positives). • Must notify collector or employer when error causes cancellation of test results • Must offer to interview donor with Positive, Adulterated, Substituted and Invalid test results. • Must review “shy bladder” medical findings • Must report medical information to employer when safety or medical qualification is an issue

42. Receive Results Review Results Interview Record Pertinent Findings Revel (in donor explanations) Reconfirm split sample Refer for Medical Evaluation Interpret Findings Report to Employer Release Medical Information Record Keep Broad MRO Role In DOT Testing MRO Responsibilities in Regulated Testing (9 R’s; 2 I’s)

43. Broad MRO Role In DOT Testing Laboratory Reporting to MRO • All test results come from lab to MRO • Cannot go to TPA or employer • Negative results can be emailed without a CCF copy • Lab must report quantitative results on all positive results • Rejected for testing, adulterated and substituted results must include standard explanatory remarks

44. Broad MRO Role In DOT Testing MRO Review of Lab Negative Results • Review lab results (electronic or CCF) • Review CCF copy 2 for flaws • Check negative on CCF copy 2 • MRO staff can conduct review and use signature stamp • MRP must personally review and sign 5% of negatives

45. Broad MRO Role In DOT Testing MRO Review of Lab Non-negative Results • Non-negative result • Positive adulterated, substituted and invalid • Must have CCF copy 1 with lab scientist’s signature • Review CCF copy 2 • Contact and interview donor

46. Broad MRO Role In DOT Testing MRO Donor Contact Process • MRO must document 3 attempts spaced over 24 hours to contact donor. • After above request, DER to contact donor • DER must document 3 attempts in 24 hours • No part of donor interview may be conducted by MRO staff

47. Broad MRO Role In DOT Testing The Medical Review Interview • Use standard check list form • Identify self and affiliation • Confirm identity of donor • Explain verification process • Inquire regarding illicit drug use • Inquire regarding Rx/OTC drug use and diet • Donor has 5 days to provide medical use documentation • If there is a legitimate medical explanation, the test is reported as negative

48. Broad MRO Role In DOT Testing MRO Results Reporting • MRO must review CCF copy 2 before reporting any DOT test results • Negative results may be transmitted electronically • Non-negative results must have MRO’s signature MRO Record Keeping • Must maintain all CCF copy 2 with signature or stamps with initials • Negatives – 1 year • Non-negatives – 5 years • Drug test results should be separated from patient medical chart because of confidentiality concerns.

49. Broad MRO Role In DOT Testing MRO’s and Medical Confidentiality • MRO’s are required to release medical information to third party (employer physician, etc.) if the information is: • Likely to result in disqualification or • Continued performance of the employee’s safety sensitive functions likely poses a significant safety risk

50. Differences Between DOT & Non-DOT Drug Testing • Tests for additional drugs beyond the 5 drug panel used in DOT • Tests are different (usually lower) cut-offs than the DOT • Single specimen tests rather than split specimen tests • Use of test specimens other than urine • Collection of prescription medication information at the time of specimen collection • Immediate removal of workers from duty pending review by the MRO if they have lab positive results.