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 2007Drug testing rate was reduced from 50% to 25% in 2007 The testing rate remains unchangedThe testing rate remains unchanged Alcohol testing rate remains the same at 10%Alcohol testing rate remains the same at 10%

DOT AgencyRegulationIndustry FMCSA Federal Motor Carrier Safety Administration49 CFR Part 382Motor Carrier FAA Federal Aviation Administration14 CFR 121 Appendices I & J Air Carriers or operators and certain contract air traffic control towers FRA Federal Railroad Administration49 CFR Part 219Rail FTA Federal Transit Administration49 CFR Part 655Public Transportation PHMSA Pipeline and Hazardous Materials Safety Administration49 CFR Part 199Operators of pipeline facilities and contractors performing covered functions for the operator USCG US Coast Guard [Department of Homeland Security] 46 CFR Parts 4 & 16Maritime

MRO’s Role Independent and Impartial AdvocateIndependent and Impartial Advocate Gatekeeper for the integrity and accuracy of the drug testing processGatekeeper for the integrity and accuracy of the drug testing process Quality assurance reviewQuality assurance review Timely FlowTimely Flow ConfidentialityConfidentiality

Qualifications Licensed physicianLicensed physician Basic knowledge of SA disordersBasic knowledge of SA disorders Qualification trainingQualification training Certification examinationCertification examination Continuing educationContinuing education

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

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

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

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

MRO Functions Review of all laboratory confirmed drug tests:Review of all laboratory confirmed drug tests: PositivesPositives AdulteratedAdulterated SubstitutedSubstituted InvalidInvalid

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.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.

Positive Drug Tests Direct contact with the employee or candidateDirect contact with the employee or candidate Verify the test as negative, positive, or test cancelledVerify the test as negative, positive, or test cancelled

Cocaine Positive 2 nd most common drug of abuse for workplace testing programs2 nd most common drug of abuse for workplace testing programs Medical uses uncommon (topical, nasal and dental)Medical uses uncommon (topical, nasal and dental) Used in combination with many other drugsUsed in combination with many other drugs Snorted, inhaled, injected and used orallySnorted, inhaled, injected and used orally

Urine Cocaine is metabolized to benzoylecgonineCocaine is metabolized to benzoylecgonine Rapid excretion within in as little as 1-3 daysRapid excretion within in as little as 1-3 days

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

Marijuana Cannabis sativa plantCannabis sativa plant CannabinoidCannabinoid THCTHC Medical uses MarinolMedical uses Marinol Schedule III drug Approved for treatment of nausea, appetite stimulant

Marijuana Decriminalization 11 states- Alaska, Arizona, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont, and Washington11 states- Alaska, Arizona, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont, and Washington Does not establish system for providing marijuanaDoes not establish system for providing marijuana Federal law it remains illegalFederal law it remains illegal

Marijuana Effects Schedule I drugSchedule I drug HallucinogenHallucinogen DrowsinessDrowsiness Impaired concentration and perceptual skillsImpaired concentration and perceptual skills Withdrawal- nausea, insomnia, irritability, anxietyWithdrawal- nausea, insomnia, irritability, anxiety

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

Hair Lower cutoffsLower cutoffs Single use is unlikely to result in a positive testSingle use is unlikely to result in a positive test

Oral Fluid Target parent drug THCTarget parent drug THC Deposited in the oral cavity during useDeposited in the oral cavity during use Concentration rise quickly and fall rapidly in the first hourConcentration rise quickly and fall rapidly in the first hour Cutoff are recommended very lowCutoff are recommended very low

Amphetamines AmphetamineAmphetamine Methamphetamine,Methamphetamine, Methylenedioxyamphetamine (MDA) andMethylenedioxyamphetamine (MDA) and Methylenedioxymethamphetamine (MDMA).Methylenedioxymethamphetamine (MDMA).

Opiate Positive 6-AM verify positive6-AM verify positive In the absence of 6-AM At 15,000 ng/ml or > verify positive unless legitimate medical explanationAt 15,000 ng/ml or > verify positive unless legitimate medical explanation At levels < 15,000 ng/ml determine if clinical evidence existsAt levels < 15,000 ng/ml determine if clinical evidence exists

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

Specimen Validity Testing Discuss with certifying scientist if the primary specimen should be tested at another HHS certified laboratoryDiscuss 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 resultIf 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 useIf 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

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 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.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.

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

Adulterated or Substituted Tests Direct contact with the employee or candidateDirect contact with the employee or candidate Determine the factual information from the laboratoryDetermine the factual information from the laboratory Verify the test as refusal to testVerify the test as refusal to test

Dilute samples Creatinine > or equal to 2 and or equal to 2 and < 20mg/dl and Specific gravity > but but <

Substituted sample Creatinine < 2 mg/dl andCreatinine < 2 mg/dl and Specific gravity < or equal to Specific gravity < or equal to or > or equal to or > or equal to

Adulterated samples pH or equal to 11pH or equal to 11 Nitrite concentration > or equal to 500 mcg/mlNitrite concentration > or equal to 500 mcg/ml An exogenous substance is presentAn exogenous substance is present

Adulterated or Substituted Tests Direct contact with the employee or candidateDirect contact with the employee or candidate Determine the factual information from the laboratoryDetermine the factual information from the laboratory Verify the test as refusal to testVerify the test as refusal to test

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

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

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

MRO Verification without Interview Employee expressly declines to speak with you.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.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 elapsedNeither you or the DER has been able to make contact with the employee and more than 10 days have elapsed

Common Errors CorrectableCorrectableCollector 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)

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

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

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

Shy Bladder Collection After the first failed attempt of less than 45 cc urine (split)After the first failed attempt of less than 45 cc urine (split) 3 hour window3 hour window Instructed to drink 40 oz of water over the 3 hours (~8 oz of water/30 minutes)Instructed to drink 40 oz of water over the 3 hours (~8 oz of water/30 minutes)

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

Other samples for testing Not currently approved under 49CFR 655 Oral FluidOral Fluid SweatSweat HairHair

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

Preventive measures RoutineRoutine FormsForms MRO checklistMRO checklist

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Questions & Answers Michelle Alexander, MD will be available for questions immediately following this presentation Room