a day in the life of an mro - datia · a day in the life of an mro david w. paine, m.d., faafp...
TRANSCRIPT
4/30/18
1
A Day in the Life of an MRO
David W. Paine, M.D., FAAFPMedical Review Officer
HowtoMakeMyDay!J
Goals• TheEssenceofMROpractice
– OverviewofMROprocess
• “Donor”issues• RoleofServiceAgents
– Collector,Lab,MRO,SAP– InterfacewithotherServiceAgentsiskey!!!– Howweimpacteachother(tohelporhurt)
• DesignatedEmployerRepresentative(DER)• Federal/StateIssues
2
Acronyms• EmployeeandDonor referencethesameperson
– (Part40alsointerchangestheseterms)• DOTandODAPC-- bothrefertoODAPC• Mode=DOTAgency(e.g.,PHMSA,FMCSA,FAA,etc.)
• “DER”=D-E-R=DesignatedEmployerRepresentative
• D.O.=DirectlyObserved• C/TPA=Consortium/ThirdPartyAdministrator• RC(orRS)=ReasonableCause/Suspicion
3
4/30/18
2
The Donor• Deservesafair,accuratetestingprocessfromcollectiontoreporting– Doitright!
• Rememberitisapersontakingadrugtest• The“ickfactor”ofdrugtesting
– Createsacertainlevelofanxietyinmostpeople--evenifnotdoingdrugs!
– Isitfairandaccurate?• Frequentlyhasminimalknowledgeofdrugtestingprocess– Explainyourpartclearly
4
MRO ProcessOverview• WhatisanMRO?• Roleintheprocess• Mixtureofregulations,policyandtoxicology&medicine
5
OverviewTheessenceoftheMROpracticeistheinterpretationofforensicdrugtestingresultswithinthecontextofapolicyorregulatoryframework&tointerfacewiththedonortodiscussresultsandfacilitateappropriateactionsandrequests.
TedShults,MS,JDAAMRO
6
4/30/18
3
• Licensedphysician(M.D.orD.O.)• Receivesandreviews(drugtest)laboratoryresults• Evaluatesmedicalexplanationsforcertaindrugtestresults
• Independentandimpartial"gatekeeper”• Advocatefortheaccuracyandintegrity• Qualityassurancereview• Determinesifthereisalegitimatemedicalexplanation• Ensuresthetimelyflowoftestresultandotherinformationtoemployers
• Protectstheconfidentiality
MRO
7https://www.transportation.gov/odapc/mro
TestResult
Negative Non-Negative
ReviewDocumentation Review
Documentation
ReportResult
DonorInterview
Stand-down(rare)
Split-specimen
PositivePositive-DiluteAdult/SubInvalid
Negative-Dilute
Recollect:Mandatory(observed)orOptional(Notobserved)
MRO’s Daily Duties
Non-contactwithdonor
8
SeekDER’shelpfindingdonor
Refusals
Lifecycle of a Drug Test
9CopyrightAMRO2017
KenEdgell,AMRO
4/30/18
4
• GoodcorporateD&Aplan– Keepuptodate– Decideontestingpanel(DOTisfixedbytheFeds;Non-DOTcanbetailored)
– EmployeeandSupervisorTraining– Consequencesclearlyspelledout– EmployeeAcknowledgmentofPolicy—Keeponfile!
• DERknowledgeableofD&Aplan– DaytoDayimplementation– Mindfulofconsistencyinapplication&ADA/EEOC/OSHArequirements
– Beabletodefendincourt
EmployerResponsibilities(Pre-Collection)
10
• Returntodutyprocess– Knowinadvancewhatyouintendtodo:allowRTDprocessornot?
• Clientrequirements• Businessrisk
• MRORole– AccessibletoDER– Policy&Regulatoryissues
• Testingsituations/problemcollections• ReportingofNonnegativeresults—timeisoftheessenceinmanycases!
EmployerResponsibilities(Pre-Collection)
11
• It’satoughjob!– Timeconstraints,documentation,regulations– Unrulydonors!
• Performagood,“bythebook”collection– FacilityshouldmeetDOTstandards– Welltrainedstaffwithreadyaccesstosupportforproblemcollections– FullycompleteCCF—includingaddress/phone/fax
• laborMROmayneedtoreachyoubyphoneorfax– Labsfaxmemorandumstocollectorstheydonotcall
– ElectronicCCFs—trainforatypicalcollectionstoavoiderrorsanddelays.• Detailsareimportant
– Significantimpactfromshortcuts• FatalFlaws• Correctableflaws
– Addtimetocompletedrugtestprocesscompletion• Legalimpact
– Errors&omissionswillbepickedapartincourt
Collector
12
4/30/18
5
• GetCopy2totheMRO!– MROswasteenormousamountsoftimetryingtoobtainCopy2from
collectors
• GetthesampletothecorrectLaboratory!– Shipitquickly– Keeptrackingnumber
• MRORole– Resourceforquestions– Impactofcollectorflaws
oruncleardocumentation
Collector
13
1. No CCF with specimen*2. No specimen with CCF*3. No printed collectors name and no signature4. Two separate collections on one CCF*5. Specimen ID number on specimen bottles and CCF do
not match6. Specimen bottle seal is broken or shows evidence of
tampering and split cannot be re-designated7. Insufficient volume of urine in primary bottle and split
cannot be re-designated
§40.83 - Reject for Testing
Fatal Flaws 2018
14
*newDOTFatalflawsfor2018
• Labwillattempttocorrectthese:– Collector’ssignatureomitted– CCFreceivedisaNon-FederalorexpiredFedCCF
• MROtoattempttocorrect:– EmployeesignatureomittedfromCCF
• Unlessemployee’sfailureorrefusalalreadynotated
– CertifyingScientistsignatureomittedonCopy1
Correctable Flaws
15
4/30/18
6
Laboratory
16
• Receivessamples,reviewsdocumentation,– Accurateandefficienttesting
• ScreeningbyImmunoassay• ConfirmationbyGC/MS*orLC/MS/MS**
– ReportingtoMRO– AccessibleforMROstoclarifyresults/interpretation
– Splittestprocessing(ifrequested)– Legaltestimonysupport
*GC/MS—Gaschromatography/Massspectrometry**LC/MS/MS—Liquidchromatography/dualmassspectrometry
• Negative– CCFfromcollector(Copy2)– Testresultfromlab
• MRO/staff—SignCopy2– ReportresultviaCopy2,Letterformatreportorelectronically– MusthavesignedCopy2onfile– NegativereporttoEmployerdirectlyorviaC/TPA
• Non-negative– (Positive,Adulterated,Substituted,Invalid,Canceled)
• Need:Labreport,LabsignedCopy1,Copy2• Preparedocumentsfordonorinterviewasappropriate
Results
17
• Identifydonor– TypicallyfromSSNorEmp IDontheCCF– Date/time/locationofcollection– Importantforcollectorstohavedocumentedthisaccuratelyandlegibly-
• hardtoreadphonenumbersanddonorIDsdelaytheprocess!
• Advisedonorofresult• MedicalMiranda
Donor Interview
18
4/30/18
7
• Goal—istherealegitimatemedicalexplanationforthedrug(s)found?
• Specificquestionsrelatedtothedrug(s)found• Medicationreview
– Prescriptions– Overthecountermedications– Foreigncountrymedications
• VerifyResult– Negative(afterproofofRx)– Positive—nolegitimatemedicalexplanation– RefusalduetoAdulterationorSubstitution– Canceled
• Invalid• FatalflaworuncorrectedCorrectableflaw
19
Donor Interview
• Negative• Non-negative
– PositiveorRefusal• Decisionpoint:Retainorletthedonorgo• ListofSAPstodonor
• Splitoption– MROrequiredbyregulationtoofferforPositive,AdulteratedorSubstituted
result.• Employermaynotrefusetoallowit(DOT)evenifhastopayforit
• DecisionPoint:• Knowinadvancewhatyouintendtodo:allowRTDprocessornot?• Clientrequirements• Businessrisk
• Employerpolicieson:– Non-DOT–Marijuana– Medicationnotification/Fitnessforduty
Employer
20
receives Final Result
DOT Fitness for Duty 2018MRO--DER
• SafetyConcern(“5DayPause”)• MROnotesmedicationthatraisessafetyconcern– DonormustprovevalidRxtoMRO
• MROthenreportsNegativetestimmediately
– “5DayPause”starts• Donorhas5businessdaystohavetheirdoctorcontactMROto changemedication/treatmenttoonesafeforthejob
https://www.transportation.gov/odapc/Part_40_DOT_Employee_Notice_2017
21
4/30/18
8
DOT Fitness for Duty 2018• MROcannotcontactDERunless/until
– 5dayselapsew/ocontactfromdonor’sphysician,or– MROstillhassafetyconcerndespitecontactwithphysician
• Employer– Processmaytakeover14daysbeforeDERisawareofsafetyconcern
– Needtohavemedicationpoliciesinplacetoaddressmedicationsafetyconcernsupfront
– CannolongerrelyontimelycontactfromMRO– Problemismuchbiggeranyway—
• MRO’sonlyidentifythesmallsubsetofemployeesonmedicationswhohappentohavetakenadrugtest
–MANYmoreonconcerningmedications!!!
22
• Crucialroleinthereturntodutyprocess– Protectingpublicsafety– Advocateforneithertheemployernortheemployee.– Protectpublicsafetybyprofessionallyevaluatingtheemployeeandrecommendingappropriateeducationand/ortreatment,follow-uptests,andaftercare.
• SAP—MRO– PleaseproperlyIDyourselftoMRO!
• Mayneedtosendcredentials– DiscussMROinterview(consistencywithSAPinterview?)
• testresult,quantitativelevels(limitedrole),alternativeexplanations
– Forensictoxicology—whatdoestheresultmean?• MarijuanaandresidualTHC
SAP
23
• ServiceAgentsneedtofollowtheregulations– FairandConsistentforallinvolved– Legallydefensible
• Feds—MRO– Regulatorysupport/caseguidance– Feedback--whatweareseening “inthefield”
• Bepartoftheprocess– CommentonNPRMs– Speakuptoimprovetheprogram
Regulations
24
4/30/18
9
• ReadandfollowPart40forDOTtests– SamefundamentalsforNonDOT
• Havegoodpolicies/proceduresinplace• Keepuptodateandyourstaffwelleducated• Worktogether!
– RealizetheimpactyouhaveonotherServiceAgents• Participateinregulatoryprocess
– NPRMs– Feedbacktoregulators
• Regulators—Pleaseseekourfeedback– Wehavemuchtoofferfromourwork“inthefield’
Key Points
25
Questions?
DavidW.Paine,M.D.,FAAFPMedicalReviewOfficerAmericanMedicalReviewOfficers,LLC
26