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The Role of the Medical Review Officer

The Role of the Medical Review Officer. Michelle Alexander, MD. Random Drug and Alcohol Testing Rates For FTA 2009. Drug testing rate was reduced from 50% to 25% in 2007 The testing rate remains unchanged Alcohol testing rate remains the same at 10%. MRO’s Role.

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The Role of the Medical Review Officer

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  1. The Role of the Medical Review Officer Michelle Alexander, MD

  2. Random Drug and Alcohol Testing Rates For FTA 2009 • Drug testing rate was reduced from 50% to 25% in 2007 • The testing rate remains unchanged • Alcohol testing rate remains the same at 10%

  3. MRO’s Role • Independent and Impartial Advocate • Gatekeeper for the integrity and accuracy of the drug testing process • Quality assurance review • Timely Flow • Confidentiality

  4. Qualifications • Licensed physician • Basic knowledge of SA disorders • Qualification training • Certification examination • Continuing education

  5. Confidentiality • Results released only to authorized persons or parties (DER, SAP, DOT, C/TPA etc.) • Results released only after verification • Quantitative results are only released to the SAP and employee • Confidential retention of records

  6. Relationships Laboratory Designated Employer Representative (DER) Collectors Substance Abuse Professionals (SAP) Third Party Administrators (TPA)

  7. MRO Functions • Review of negative tests Personal review of 5% of all CCFs and all results that require a corrective action quarterly up to 500 tests

  8. Negative tests • Immunoassay results are below the initial test cutoffs or • GC/MS results below the confirmatory cutoffs, and • Specimen validity test results in the acceptable range.

  9. MRO Functions • Review of all laboratory confirmed drug tests: • Positives • Adulterated • Substituted • Invalid

  10. MRO Miranda • Explain at the start of the interview that the information provided to you in the course of determining if a legitimate medical explanation exists can be shared with the employer, DOT and other agencies. In addition, if such information affects workplace safety or indicates that the employee is otherwise not medically qualified the employer can be notified.

  11. Positive Drug Tests • Direct contact with the employee or candidate • Verify the test as negative, positive, or test cancelled

  12. Cocaine Positive • 2nd most common drug of abuse for workplace testing programs • Medical uses uncommon (topical, nasal and dental) • Used in combination with many other drugs • Snorted, inhaled, injected and used orally

  13. Urine • Cocaine is metabolized to benzoylecgonine • Rapid excretion within in as little as 1-3 days

  14. Hair • Test for benzoylecgonine, cocaethylene, and norcocaine • Hair washing is performed to eliminate issues of passive exposure • Some evidence of metabolite must be present to confirm positives • Single use is unlikely to result in a positive test • Hair color

  15. Marijuana • Cannabis sativa plant • Cannabinoid • THC • Medical uses Marinol Schedule III drug Approved for treatment of nausea, appetite stimulant

  16. Marijuana Decriminalization • 11 states- Alaska, Arizona, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont, and Washington • Does not establish system for providing marijuana • Federal law it remains illegal

  17. Marijuana Effects • Schedule I drug • Hallucinogen • Drowsiness • Impaired concentration and perceptual skills • Withdrawal- nausea, insomnia, irritability, anxiety

  18. Urine • About 30% metabolized to THCA • Urine positive for 1-21 days (infrequent vs. frequent use)

  19. Hair • Lower cutoffs • Single use is unlikely to result in a positive test

  20. Oral Fluid • Target parent drug THC • Deposited in the oral cavity during use • Concentration rise quickly and fall rapidly in the first hour • Cutoff are recommended very low

  21. Amphetamines • Amphetamine • Methamphetamine, • Methylenedioxyamphetamine (MDA) and • Methylenedioxymethamphetamine (MDMA).

  22. Opiate Positive • 6-AM verify positive In the absence of 6-AM • At 15,000 ng/ml or > verify positive unless legitimate medical explanation • At levels < 15,000 ng/ml determine if clinical evidence exists

  23. Specimen Validity Testing • Direct observation required for all return to work and follow-up collections • Mandatory within all regulated transportation industries • Requires the laboratories to report Creatinine and Specific gravity values for all specimens they report as dilute • If the test is reported as dilute (negative) with Creatinine ≥ 2 mg/dl but < 5mg/dl the direct recollection immediately under direct observation

  24. Specimen Validity Testing • Discuss with certifying scientist if the primary specimen should be tested at another HHS certified laboratory • If no further testing required then the donor is contacted to determine if a valid medical explanation exists for the invalid result • If a negative result is required and the donor has a permanent or long term condition, the MRO must determine if there is clinical evidence of illicit drug use

  25. Specimen Validity Testing • If the donor admits to illicit drug use the MRO must report this to the employer as a safety concern. The test is reported as cancelled. • If the second test is invalid and the reason is the same as the first test, and a negative test result is required, the MRO must make a clinical determination if there is illicit drug use.

  26. Specimen Validity Testing • Re-test for adulterants-must test for adulterant(s) using the same criteria • Re-test for substitution must use same criteria as the initial laboratory

  27. Adulterated or Substituted Tests • Direct contact with the employee or candidate • Determine the factual information from the laboratory • Verify the test as refusal to test

  28. Dilute samples • Creatinine > or equal to 2 and < 20mg/dl and • Specific gravity > 1.0010 but < 1.0030

  29. Substituted sample • Creatinine < 2 mg/dl and • Specific gravity < or equal to 1.0010 or > or equal to 1.0200

  30. Adulterated samples • pH < 3 or > or equal to 11 • Nitrite concentration > or equal to 500 mcg/ml • An exogenous substance is present

  31. Adulterated or Substituted Tests • Direct contact with the employee or candidate • Determine the factual information from the laboratory • Verify the test as refusal to test

  32. Common Adulterants • Nitrites (Klear, Whizzies) • Alkylephoxysulfonate (Mary Jane’s Super Clean) • NaCl (table salt) • UrinAid (Glutaraldehyde) • Urine Luck (Pyridine)

  33. Invalid specimens Creatinine concentration & specific gravity results are discrepant: • Creatinine < 2 mg/dl & specific gravity > or equal to 1.0010 and < 1.0200 • Creatinine > or equal to 2mg/dl & specific gravity < or equal to 1.0010

  34. Invalid specimens cont’d pH outside acceptable range • pH is > or equal to 3 and < 4.5; or • pH > or equal to 9 and< 11 Nitrite present • Nitrite > or equal to 200mcg/ml

  35. MRO Verification without Interview • Employee expressly declines to speak with you. • After 3 unsuccessful attempts to contact the employee (both day and evening) over a 24 hour period and the DER has made such contact and more than 72 hrs have elapsed. • Neither you or the DER has been able to make contact with the employee and more than 10 days have elapsed

  36. Common Errors • Correctable Collector Donor ID number omitted or incorrect on CCF (unless refusal) Collectors signature missing certification statement Incomplete COC block (at least 2 signatures and dates, shipping entry)

  37. Common Errors Correctable • Donor signature missing from certification statement (unless refusal) • Using incorrect CCF (DOT vs. non DOT) Lab • Certifying scientist signature omitted on positives

  38. Fatal Flaws • Specimen ID missing from specimen bottle or fails to match • Volume less than 30 ml • Specimen seal is broken or shows evidence of tampering • Specimen shows obvious adulteration (color, foreign objects, unusual odor, etc)

  39. Blind Samples • Submitted with donor samples • These samples should be verified: Negative Drug Positive Adulterated Substituted

  40. Shy Bladder Collection • After the first failed attempt of less than 45 cc urine (split) • 3 hour window • Instructed to drink 40 oz of water over the 3 hours (~8 oz of water/30 minutes)

  41. Failure to provide sufficient sample for testing • Obtain a detailed medical history ASAP. • Refer to an appropriate trained physician acceptable to you. • Consider information provided to you by this physician and make your determination.

  42. Other samples for testing Not currently approved under 49CFR 655 • Oral Fluid • Sweat • Hair

  43. Recommendations • Education! • Collectors and DERs • Physicians used to make medical determinations (shy bladder, lung/refusals)

  44. Preventive measures • Routine • Forms • MRO checklist

  45. Interesting websites • http://www.passyourdrugtest.com/ • http://www.cleartest.com/ • http://www.detoks.com/

  46. Questions & Answers Michelle Alexander, MD will be available for questions immediately following this presentation Room 209-210

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