The Role of the Medical The Role of the Medical Review OfficerReview Officer

Michelle Alexander, MDMichelle Alexander, MD

Random Drug and Alcohol Random Drug and Alcohol Testing Rates For FTA Testing Rates For FTA

20092009• Drug testing rate was reduced Drug testing rate was reduced

from 50% to 25% in 2007from 50% to 25% in 2007• The testing rate remains The testing rate remains

unchangedunchanged• Alcohol testing rate remains the Alcohol testing rate remains the

same at 10%same at 10%

DOT Agency Regulation Industry

FMCSA Federal Motor Carrier Safety Administration 49 CFR Part 382 Motor Carrier

FAA Federal Aviation Administration 14 CFR 121Appendices I & J

Air Carriers or operators and certain contract air traffic control towers

FRA Federal Railroad Administration 49 CFR Part 219 Rail

FTA Federal Transit Administration 49 CFR Part 655 Public Transportation

PHMSA Pipeline and Hazardous Materials Safety Administration 49 CFR Part 199 Operators of pipeline facilities and contractors performing covered functions for the operator

USCG US Coast Guard[Department of Homeland Security]

46 CFR Parts 4 & 16 Maritime

MRO’s RoleMRO’s Role

• Independent and Impartial AdvocateIndependent and Impartial Advocate• Gatekeeper for the integrity and Gatekeeper for the integrity and

accuracy of the drug testing processaccuracy of the drug testing process• Quality assurance reviewQuality assurance review• Timely FlowTimely Flow• ConfidentialityConfidentiality

QualificationsQualifications

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

ConfidentialityConfidentiality

• Results released only to authorized Results released only to authorized persons or parties (DER, SAP, DOT, persons or parties (DER, SAP, DOT, C/TPA etc.)C/TPA etc.)

• Results released only after Results released only after verificationverification

• Quantitative results are only Quantitative results are only released to the SAP and employeereleased to the SAP and employee

• Confidential retention of recordsConfidential retention of records

RelationshiRelationshipsps

LaboratoryLaboratory

Designated Employer Designated Employer Representative (DER)Representative (DER)

Collectors Collectors

Substance Abuse Substance Abuse Professionals (SAP)Professionals (SAP)Third Party Third Party Administrators (TPAAdministrators (TPA))

MRO FunctionsMRO Functions

• Review of negative testsReview of negative tests

Personal review of 5% of all Personal review of 5% of all CCFs and all results that require a CCFs and all results that require a corrective action quarterly up to corrective action quarterly up to 500 tests500 tests

Negative testsNegative tests

• Immunoassay results are below Immunoassay results are below the initial test cutoffs the initial test cutoffs oror

• GC/MS results below the GC/MS results below the confirmatory cutoffs, confirmatory cutoffs, andand

• Specimen validity test results in Specimen validity test results in the acceptable range.the acceptable range.

MRO FunctionsMRO Functions

• Review of all laboratory confirmed Review of all laboratory confirmed drug tests:drug tests:

• PositivesPositives• AdulteratedAdulterated• Substituted Substituted • InvalidInvalid

MRO MirandaMRO Miranda

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

Positive Drug TestsPositive Drug Tests

• Direct contact with the employee Direct contact with the employee or candidate or candidate

• Verify the test as negative, Verify the test as negative, positive, or test cancelledpositive, or test cancelled

Cocaine PositiveCocaine Positive

• 22ndnd most common most common drug of abuse for drug of abuse for workplace testing workplace testing programsprograms

• Medical uses Medical uses uncommon (topical, uncommon (topical, nasal and dental)nasal and dental)

• Used in combination Used in combination with many other drugswith many other drugs

• Snorted, inhaled, Snorted, inhaled, injected and used injected and used orallyorally

UrineUrine

• Cocaine is metabolized to Cocaine is metabolized to benzoylecgoninebenzoylecgonine

• Rapid excretion within in as little Rapid excretion within in as little as 1-3 daysas 1-3 days

HairHair

• Test for benzoylecgonine, cocaethylene, Test for benzoylecgonine, cocaethylene, and norcocaineand norcocaine

• Hair washing is performed to eliminate Hair washing is performed to eliminate issues of passive exposureissues of passive exposure

• Some evidence of metabolite must be Some evidence of metabolite must be present to confirm positivespresent to confirm positives

• Single use is unlikely to result in a Single use is unlikely to result in a positive testpositive test

• Hair colorHair color

MarijuanaMarijuana

• Cannabis sativa Cannabis sativa plantplant

• CannabinoidCannabinoid• THCTHC• Medical uses MarinolMedical uses Marinol

Schedule III drugSchedule III drug

Approved for Approved for treatment of treatment of nausea, appetite nausea, appetite stimulantstimulant

Marijuana Marijuana DecriminalizationDecriminalization

• 11 states- Alaska, Arizona, 11 states- Alaska, Arizona, California, Colorado, Hawaii, California, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Maine, Montana, Nevada, Oregon, Vermont, and WashingtonVermont, and Washington

• Does not establish system for Does not establish system for providing marijuanaproviding marijuana

• Federal law it remains illegal Federal law it remains illegal

Marijuana EffectsMarijuana Effects

• Schedule I drugSchedule I drug• HallucinogenHallucinogen• DrowsinessDrowsiness• Impaired concentration and Impaired concentration and

perceptual skillsperceptual skills• Withdrawal- nausea, insomnia, Withdrawal- nausea, insomnia,

irritability, anxietyirritability, anxiety

UrineUrine

• About 30% metabolized to THCAAbout 30% metabolized to THCA• Urine positive for 1-21 days Urine positive for 1-21 days

(infrequent vs. frequent use)(infrequent vs. frequent use)

HairHair

• Lower cutoffs Lower cutoffs • Single use is unlikely to result in a Single use is unlikely to result in a

positive testpositive test

Oral FluidOral Fluid

• Target parent drug THCTarget parent drug THC• Deposited in the oral cavity during Deposited in the oral cavity during

useuse• Concentration rise quickly and fall Concentration rise quickly and fall

rapidly in the first hour rapidly in the first hour • Cutoff are recommended very low Cutoff are recommended very low

AmphetaminesAmphetamines

• Amphetamine Amphetamine • Methamphetamine, Methamphetamine, • Methylenedioxyamphetamine Methylenedioxyamphetamine

(MDA) and (MDA) and • Methylenedioxymethamphetamine Methylenedioxymethamphetamine

(MDMA).(MDMA).

Opiate PositiveOpiate Positive

• 6-AM verify positive6-AM verify positive

In the absence of 6-AM In the absence of 6-AM • At 15,000 ng/ml or > At 15,000 ng/ml or >

verify positive unless verify positive unless legitimate medical legitimate medical explanationexplanation

• At levels < 15,000 At levels < 15,000 ng/ml determine if ng/ml determine if clinical evidence clinical evidence existsexists

Specimen Validity Specimen Validity TestingTesting

• Direct observation required for all return Direct observation required for all return to work and follow-up collectionsto work and follow-up collections

• Mandatory within all regulated Mandatory within all regulated transportation industriestransportation industries

• Requires the laboratories to report Requires the laboratories to report Creatinine and Specific gravity values Creatinine and Specific gravity values for all specimens they report as dilutefor all specimens they report as dilute

• If the test is reported as dilute If the test is reported as dilute (negative) with Creatinine ≥ 2 mg/dl (negative) with Creatinine ≥ 2 mg/dl but < 5mg/dl the direct recollection but < 5mg/dl the direct recollection immediately under direct observationimmediately under direct observation

Specimen Validity Specimen Validity TestingTesting

• Discuss with certifying scientist if the Discuss with certifying scientist if the primary specimen should be tested at primary specimen should be tested at another HHS certified laboratoryanother HHS certified laboratory

• If no further testing required then the If no further testing required then the donor is contacted to determine if a valid donor is contacted to determine if a valid medical explanation exists for the invalid medical explanation exists for the invalid resultresult

• If a negative result is required and the If a negative result is required and the donor has a permanent or long term donor has a permanent or long term condition, the MRO must determine if condition, the MRO must determine if there is clinical evidence of illicit drug usethere is clinical evidence of illicit drug use

Specimen Validity Specimen Validity TestingTesting

• If the donor admits to illicit drug use the MRO If the donor admits to illicit drug use the MRO must report this to the employer as a safety must report this to the employer as a safety concern. The test is reported as cancelled.concern. The test is reported as cancelled.

• If the second test is invalid and the reason is If the second test is invalid and the reason is the same as the first test, and a negative test the same as the first test, and a negative test result is required, the MRO must make a result is required, the MRO must make a clinical determination if there is illicit drug use.clinical determination if there is illicit drug use.

Specimen Validity Specimen Validity TestingTesting

• Re-test for adulterants-must test Re-test for adulterants-must test for adulterant(s) using the same for adulterant(s) using the same criteriacriteria

• Re-test for substitution must use Re-test for substitution must use same criteria as the initial same criteria as the initial laboratorylaboratory

Adulterated or Adulterated or Substituted TestsSubstituted Tests

• Direct contact with the employee Direct contact with the employee or candidateor candidate

• Determine the factual information Determine the factual information from the laboratoryfrom the laboratory

• Verify the test as refusal to testVerify the test as refusal to test

Dilute samplesDilute samples

• Creatinine > or equal to 2 and < Creatinine > or equal to 2 and < 20mg/dl 20mg/dl andand

• Specific gravity > 1.0010 but < Specific gravity > 1.0010 but < 1.0030 1.0030

Substituted sampleSubstituted sample

• Creatinine < 2 mg/dl Creatinine < 2 mg/dl andand• Specific gravity < or equal to Specific gravity < or equal to

1.0010 1.0010

or > or equal to 1.0200or > or equal to 1.0200

Adulterated samplesAdulterated samples

• pH < 3 or > or equal to 11pH < 3 or > or equal to 11• Nitrite concentration > or equal to Nitrite concentration > or equal to

500 mcg/ml500 mcg/ml• An exogenous substance is presentAn exogenous substance is present

Adulterated or Adulterated or Substituted TestsSubstituted Tests

• Direct contact with the employee Direct contact with the employee or candidateor candidate

• Determine the factual information Determine the factual information from the laboratoryfrom the laboratory

• Verify the test as refusal to testVerify the test as refusal to test

Common AdulterantsCommon Adulterants

• Nitrites (Klear, Whizzies)Nitrites (Klear, Whizzies)• Alkylephoxysulfonate (Mary Jane’s Alkylephoxysulfonate (Mary Jane’s

Super Clean)Super Clean)• NaCl (table salt)NaCl (table salt)• UrinAid (Glutaraldehyde)UrinAid (Glutaraldehyde)• Urine Luck (Pyridine)Urine Luck (Pyridine)

Invalid specimensInvalid specimens

Creatinine concentration & specific Creatinine concentration & specific gravity results are discrepant:gravity results are discrepant:

• Creatinine < 2 mg/dl & specific Creatinine < 2 mg/dl & specific gravity > or equal to 1.0010 and < gravity > or equal to 1.0010 and < 1.02001.0200

• Creatinine > or equal to 2mg/dl &Creatinine > or equal to 2mg/dl &

specific gravity < or equal to 1.0010 specific gravity < or equal to 1.0010

Invalid specimens Invalid specimens cont’dcont’d

pH outside acceptable rangepH outside acceptable range• pH is > or equal to 3 and < 4.5; orpH is > or equal to 3 and < 4.5; or• pH > or equal to 9 and< 11pH > or equal to 9 and< 11

Nitrite presentNitrite present• Nitrite > or equal to 200mcg/mlNitrite > or equal to 200mcg/ml

MRO Verification without MRO Verification without InterviewInterview

• Employee expressly declines to speak with Employee expressly declines to speak with you.you.

• After 3 unsuccessful attempts to contact After 3 unsuccessful attempts to contact the employee (both day and evening) over the employee (both day and evening) over a 24 hour period and the DER has made a 24 hour period and the DER has made such contact and more than 72 hrs have such contact and more than 72 hrs have elapsed.elapsed.

• Neither you or the DER has been able to Neither you or the DER has been able to make contact with the employee and more make contact with the employee and more than 10 days have elapsedthan 10 days have elapsed

Common ErrorsCommon Errors

• CorrectableCorrectable

CollectorCollector

Donor ID number omitted or incorrect on Donor ID number omitted or incorrect on CCFCCF

(unless refusal) (unless refusal)

Collectors signature missing certification Collectors signature missing certification statementstatement

Incomplete COC block (at least 2 Incomplete COC block (at least 2 signatures and dates, shipping entry)signatures and dates, shipping entry)

Common ErrorsCommon Errors

CorrectableCorrectable• Donor signature missing from Donor signature missing from

certification statement (unless certification statement (unless refusal)refusal)

• Using incorrect CCF (DOT vs. non Using incorrect CCF (DOT vs. non DOT)DOT)

LabLab• Certifying scientist signature Certifying scientist signature

omitted on positivesomitted on positives

Fatal FlawsFatal Flaws

• Specimen ID missing from specimen Specimen ID missing from specimen bottle or fails to matchbottle or fails to match

• Volume less than 30 mlVolume less than 30 ml• Specimen seal is broken or shows Specimen seal is broken or shows

evidence of tamperingevidence of tampering• Specimen shows obvious adulteration Specimen shows obvious adulteration

(color, foreign objects, unusual odor, (color, foreign objects, unusual odor, etc)etc)

Blind SamplesBlind Samples

• Submitted with donor samplesSubmitted with donor samples• These samples should be verified:These samples should be verified:

NegativeNegative

Drug PositiveDrug Positive

AdulteratedAdulterated

Substituted Substituted

Shy Bladder CollectionShy Bladder Collection

• After the first failed attempt of less After the first failed attempt of less than 45 cc urine (split) than 45 cc urine (split)

• 3 hour window3 hour window• Instructed to drink 40 oz of water Instructed to drink 40 oz of water

over the 3 hours (~8 oz of over the 3 hours (~8 oz of water/30 minutes)water/30 minutes)

Failure to provide Failure to provide sufficient sample for sufficient sample for

testingtesting• Obtain a detailed medical history Obtain a detailed medical history

ASAP.ASAP.• Refer to an appropriate Refer to an appropriate trained trained

physician acceptable to you.physician acceptable to you.• Consider information provided to Consider information provided to

you by this physician and make you by this physician and make your determination.your determination.

Other samples for testingOther samples for testing

Not currently approved under 49CFR Not currently approved under 49CFR 655655

• Oral FluidOral Fluid• SweatSweat• HairHair

RecommendationsRecommendations

• Education!Education!• Collectors and DERsCollectors and DERs• Physicians used to make medical Physicians used to make medical

determinations (shy bladder, determinations (shy bladder, lung/refusals)lung/refusals)

Preventive measuresPreventive measures

• RoutineRoutine• FormsForms• MRO checklistMRO checklist

Interesting websitesInteresting websites

• http://www.passyourdrugtest.com/http://www.passyourdrugtest.com/• http://www.cleartest.com/http://www.cleartest.com/• http://www.detoks.com/http://www.detoks.com/

Questions & Answers

Michelle Alexander, MD

will be available for questions

immediately following this presentation

Room 209-210