Sleep Issues & CMV Drivers

Sleep Issues & CMV DriversOrrin Mann, MD, MPH, FACOEMOccupational, Environmental & Preventive MedicineMinnesota Sleep Society 5th Annual Meeting

Lecture OverviewCase studiesImpact of Sleepy CMV driversWhy the conundrumA drivers jobReview the RulesDescribe the regulatory issues and processReview the guidance availableQuick summary: There is no Rule for OSA.Case 151yo maleESS=3, BMI 37, Neck Circumference 19Remainder of H & P normalPSG ordered, 3 month DOT card signedEmployer upset and threatens to pull businessCase 251yo maleESS=3, BMI 37, Neck Circumference 19Remainder of H & P normalPSG NOT ordered, 2 year DOT card signedEmployers MD audits and insists on a 3 month card and a PSG, citing the Joint Task Force recommendations.

Case 363 yo male CMV driverOff work after MVA: took 3 pills, he believes they were Ambien and not HCTZ, by mistake, fell asleep, head on collision, with severe injuries to other driver.Seen elsewhere and given a DOT card.Employer requests I repeat evaluation knowing above information

Case 3 ContinuedDrug test + for Ambien, per employerH & P otherwise normalI initially cleared driver, but later changed my mind, rescinding the card until evaluated by a sleep expert, per Joint Task Force.Employer upset, disagrees with recommendation, and doesnt want to put driver through the added expense.My role todayI am not a sleep expert: You guys are.I will not debate or defend any recommendationsI will not discuss merits of Home vs. Lab PSG, MWT, MSLT, etc.I hope to clarify some of the regulatory, legal, bureaucratic, occupational, & financial issues

Tracy Morgan Critically Hurt in New Jersey MVA 6/7/14: Wall mart sued

June 2009: Miami,Oklahoma

76 year old driver falls asleep after 11 hours of drivingHits a line of Stationary cars10 dead

Sleepy DriversDrowsy driving is a leading cause of crashes and highway fatalities, according to federal officials.More than 30,000 people die on highways annually in the United States; crashes involving large trucks are responsible for one in seven of those deaths.The DOT believes that fatigue-related causes accounted for 13 percent of all trucking accidents.2002 NHTSA studyEconomic Impact of Sleepy Drivers6 million crashes annually resulting in an economic impact of over $230 billion. >17% ($39 billion) of these costs are probably attributed to sleepiness and even this estimate may be relatively low.Blincoe LJ, Seay A, Zaloshnja E, Miller TR, Romano E, Luchter S, et al. The economic impact of motor vehicle crashes, 2000. Washington, DC: National Highway Traffic Safety Administration; 2002. Sleepy DriversFederal rules 2013 reduced the maximum workweek for truckers to 70 hours, from 82 hours. Drivers who hit this limit can start their workweek only after a mandatory 34-hour resting period. Restart must include two periods between 1 a.m. and 5 a.m., to allow drivers to rest at least two nights a week. Drivers cannot drive for more than 11 hours a day and must have a 30-minute break in their schedule. (FMCSA not enforcing for short haul)Sleepy DriversDOT based its new rules on the 2006 Large-Truck Crash Causation Study: fatigue-related causes accounted for 13 percent of all trucking accidents. Federal officials caution that fatigue was often underreported in crash investigations because truck drivers do not want to acknowledge being sleepy, lest they be seen as at fault.Often difficult to find evidence that fatigue directly caused an accident. Sleepy Drivers1990 National Transportation Safety Board study of 182 heavy-truck accidents in which the truck driver diedConcluded fatigue played a role in 31 percent of the cases: more than alcohol or drugs.Extent of problem is a matter of debate, because it is difficult to obtain evidence that the dead driver fell asleep first.Sleepy Drivers: MEP Report 2008CMV drivers with OSA are at an increased risk for a crash when compared to their counterparts who do not have the disorder (Strength of Evidence: Minimal Acceptable). Crash risk for CMV driver: 0.08 MVA/person-yearCrash risk (expected) CMV driver with OSA: 0.10-0.46 MVA/person-year or as much as 5+ times higherNon-CMV drivers with OSA are at an increased risk for a motor vehicle crash when compared with comparable drivers who do not have the disorder (Strength of Evidence: Strong).

In the event of a crash with injury or death, the medical exam will be among the first things scrutinized

Why the Conundrum????Cost: PSG, CPAP, Lost incomeAnxiety: Financial, careerConfusionMixed messages from DOTLegal impediments to regulatory guidanceRules, regulations, guidance, panels, boards: Huh???Multiple contradictory recommendationsTrucking industry inconsistencyMedical field inconsistencyThe Job of a Commercial DriverDrivers duty may include:Coupling and uncoupling trailer(s) from tractorsLoading and unloadingInspecting vehicle and trailerLifting, installing and removing chains, tarpsAgility, bend, stoop, crouching, climbingDOT instructs that all CMV drivers with a medical certificate must be able to do all of these, not merely their own job!The Job of a Commercial DriverDuties may included:Abrupt schedule changes Rotating work schedulesIrregular sleep conditions Could impact CPAP compliance, and sleep qualityBeginning a trip in a fatigued conditionLong hoursExtended time away from family and friends

49 CFR 391.41Physical Qualifications for DriverA driver must haveThe perceptual skills to monitor a sometimes complex driving situationThe judgment skills to make quick decisionsThe manipulative skills to control an oversize steering wheel, shift gears using a manual transmission, and maneuver a vehicle in crowded areas.

Purpose of Interstate Commercial Driver Physical Examination

FMCSA describes the periodic physical qualification examination of the interstate CMV driver to be a "medical fitness for duty" examination. The purpose of the physical examination is to detect the presence of any physical, mental, or organic conditions of such character and extent as to affect the ability of the driver to operate a CMV safely.

The DOT ExamFirst DOT exams required January 1, 1954Standard last revised(49CFR 391.41) 1970Only MDs could perform exam till 1992. After 1992: added doctors of osteopathy, physician assistants, advanced practice nurses, and doctors of chiropractic, licensed to perform medical examinations in their state.1999: FMCSAFederal Motor Carrier Safety Administration (FMCSA) established.One branch of the Department of Transportation (DOT).One goal: ensuring safety in motor carrier operations through strong enforcement of safety regulations

FMCSA Office of Medical Programs"The mission of the Office of Medical Programs is to promote the safety of America's roadways through the promulgation and implementation of medical regulations, guidelines and policies that ensure commercial motor vehicle drivers engaged in interstate commerce are physically qualified to do so." Develops and implements medical regulations, policies, and procedures

The DOT Exam13 standards for medical fitness4 non-discretionary disqualifying standards:Seizures, insulin, vision, hearingRegulations are law and must be followed9 discretionary standardExaminer determines whether to sign the medical certificateThese are neither regulations nor laws.Discretionary standardsThe Federal Motor Carrier Safety Administration (FMCSA) provides medical Guidelines or advisory criteria based on expert review, and considered best practice.Published in the Medical Examiners Handbook: http://nrcme.fmcsa.dot.gov/documents/FMCSAMedicalExaminerHandbook-2014MAR18.pdf Discretionary standardsThe examiner may or may not choose to use these recommended guidelines. When the certification decision does not conform to the recommendations, the reason(s) for not following the medical guidelines should be included in the documentation.Legal ramifications of diverging from Guidelines.

Discretionary standardsWhere Big G guidance is unavailable, can use little g sources such as MEP or MRB recommendations, Motor Carrier Safety Advisory Committee recommendations, medical literature, consultants recommendations, or community best practices.Spring 2014: FMCSA removed all Chronic Sleep Disorders, Sleep Disorder Test Guidelines, and FAQs on OSA and EDS from the Handbook. FAQ remains on Narcolepsy: Disqualifying.Discretionary standards391.41(b)(5): Has no established medical history or clinical diagnosis of a respiratory dysfunction likely to interfere with his ability to control and drive a commercial motor vehicle (CMV) safely.391.41(b)(9): Has no mental, nervous, organic, or functional disease or psychiatric disorder likely to interfere with his ability to drive a CMV.DOT HistoryYes or No: Sleep disorders, pauses in breathing while asleep, daytime sleepiness, loud snoring.Questions on Hypertension, Diabetes and medications for these conditions.May add Epworth Sleepiness Scale, similar tools, or other questionnaires. Epworth in the setting of the DOT exam is unreliable in my experience. Drivers are either unaware of, under report, or underestimate EDS.DOT Physical ExaminationHeight and Weight: required.BMI , Neck circumference: NOT required.Yes or No: Abnormal chest wall expansion, abnormal respiratory rate, abnormal breath sounds including wheezes or alveolar rales, impaired respiratory function, cyanosis. Abnormal findings on physical exam may require further testing such as pulmonary tests and/or xray of chest.Exam of limited utility for sleep disorders

Instructions to the Medical Examiner(On the DOT exam form)There are many conditions that interfere with oxygen exchange and may result in incapacitation, includingsleep apnea. If the medical examiner detects a respiratory dysfunction, that in any way is likely to interfere with the drivers ability to safely control and drive a commercial motor vehicle, the driver must be referred to a specialist for further evaluation and therapy.1999: SAFTELUSafe, Accountable, Flexible and Efficient Transportation Equity Act: A Legacy for Users.Required Certified Driver Medical Examiners (CDME), registered on National Registry of Cerified Medical Examiners (NRCME). Effective May 21,2014. Before: 900,000 examiners. Now: 40,000 CDMEs. SAFTELUExam results are submitted to a national database. In 3 years FMCSA will forward the medical certification status to the states for inclusion in the Commercial Driver Licensing Information System (CDLIS).

Drivers with Canadian or Mexican CDLs who are operating in the United States under NAFTA agreements are not required to be examined by examiners on the NRCME.

FAQ: What happens if a driver is not truthful about his/her history on the medical examination form?Driver is required to complete the Health History section and certify that the responses are complete and true.Must certify that he/she understands that inaccurate, false or misleading information may invalidate the examination and medical examiners certificate issued based on it.A civil penalty may also be levied against the driver under 49 U.S.C. 521(b)(2)(b), either for making a false statement or for concealing a disqualifying condition.

FMCSA Standard and Guideline ReviewBased on agency experts analysis of international, national and state dataInteragency national and international regulatory analysisEvidence reports, written by FMCSA based on above itemsMedical Expert Panels (MEP)Medical Review Board (MRB)Motor Carrier Safety Advisory Committee (MCSAC)

MEPMEDICAL EXPERT PANELEach MEP is comprised of an independent panel of physicians, clinicians, and scientists who are experts in their specialty fields.An MEP is periodically commissioned by FMCSA for specific medical topics. MEP reviews the evidence in the about a question or topic, and makes recommendations to the Agency in the form of a report.This report is an opinion for consideration for FMCSA. http://www.fmcsa.dot.gov/rules-regulations/topics/mep/mep-reports.htmOnce approved, it become a Guidline.

MRBMEDICAL REVIEW BOARDThe MRB is composed of five of our Nation's most distinguished and scholarly practicing physicians. These physicians were chosen from a field of many qualified candidates who possess a wide variety of expertise and experience. MRB members specialize in the areas most relevant to the bus and truck driver population.MCSAC- Chartered 2006MOTOR CARRIER SAFETY ADVISORY COMMITTEEIs comprised of 20 experts from the motor carrier safety advocacy, safety enforcement, industry, and labor sectors.Not medical professionalsProvide advice and recommendations to the FMCSA Administrator on motor carrier safety programs and motor carrier safety regulations.See link for current members:http://mcsac.fmcsa.dot.gov/members.htmFMCSA Standard and Guideline ReviewMRB: Meets 3-4 x per yearReview Evidence Reports and MEP opinions, if an MEP has been convenedProposes recommendations to FMCSAFMCSA reviews all of this, and considers feasibility and impact.Posts proposed changes to current standards for commentMedical Examiners Handbook updated with new Standards or Guidelines May 2010: The American Sleep Apnea Association, the American Trucking Associations and the FMCSA co-sponsored a national Sleep Apnea &Trucking Conference about sleep apneas effect on truckers.April 20, 2012: FMCSA published a Proposed Regulatory Guidance for obstructive sleep apnea (OSA) and request for comment.April 27, 2012: FMCSA published a withdrawal notice on its Proposed Recommendations on Obstructive Sleep Apnea.H.R.3095, enacted Oct 15, 2013To ensure that any new or revised requirement providing for the screening, testing, or treatment of individuals operating commercial motor vehicles for sleep disorders is adopted pursuant to a rulemaking proceeding, and for other purposes.Does not prohibit enacting Guidelines (e.g. in the Handbook), but FMCSA intends to only propose new Guidelines through the notice and comment process. Net effect: Everything is delayed.FMCSA Standard and GuidelineCurrently nothing on sleep disorders is available in the Medical Examiners Handbook, and prior Guidelines have been vacated.

Current FAQ: Narcolepsy The guidelines recommend disqualifying a CMV driver with a diagnosis of Narcolepsy, regardless of treatment, because of the likelihood of excessive daytime somnolence.Trucking Industry Opposes Rule changesOn 6/6/14 Senator Susan Collins, pushed an amendment through the Senate Appropriations Committee that would freeze the rules, stating the administration had failed to take into account that the new rules would put more trucks on the roads during peak traffic hours, and safety studies are needed.Trucking officials and executives also said that drivers needed to be afforded maximum flexibility in their work and should not be told when to rest. Industry claim: rules reduce productivity.

Assessing RiskDoes the Driver Pose a Risk to Public Safety?As a medical examiner, any time you answer yes to this question, you should not certify the driver as medically fit for duty.A balance between the right or desire to work and public safety

Assessing RiskPhysical Conditions:Symptoms: Does the condition interfere with the ability to drive?Does the condition cause incapacitation?Sudden: Can driver safely stop vehicle before incapacitation or LOC?Gradual: Is the driver unaware of diminished capacity, adversely affecting safety?Assessing RiskMental conditionsCognitive: Can the driver process environmental cues rapidly and make appropriate responses, independently solve problems, and function in a dynamic environment?Behavioral: Are the driver reactions appropriate, responsible, and nonviolent?

Assessing RiskMedical treatment:Effects: Does treatment allow the driver to perform tasks safer than without treatment?Side effects: Do side effects interfere with safe driving (e.g., drowsiness, dizziness, orthostatic hypotension, blurred vision, changes in mental status)?Acceptable RiskFrom Cardiovascular Advisory Panel (MEP)Acceptable Risk is a medical and societal issueGiven the complex demands of operating a large truck or bus, coupled with the high fatality risk for occupants of the other vehicle in crashes involving CMVs, a conservative approach is required.1% annual risk of sudden incapacitation (impairment) is often used.VACATED Former FMCSA GUIDELINESChronic Sleep DisordersWaiting periodMinimum 1 month after starting CPAPMinimum 3 months symptom free after surgical treatmentMaximum certification 1 yearRecommend to certify if the driver has:Successful nonsurgical therapy with Multiple Sleep Latency Test WNLResolution of OSA confirmed by repeat sleep study during treatmentContinuous successful non surgical therapy for 1 monthCompliance with continuing nonsurgical therapyResolution of symptoms following completion of post-surgical waiting period

VACATED Former FMCSA GUIDELINESChronic Sleep DisordersRecommend not to certify if the driver has:Hypoxemia at restDiagnosis of:Untreated symptomatic OSANarcolepsyPrimary (idiopathic) alveolar hypoventillation syndromeIdiopathic CNS hypersonmolenceRLS with EDSThe driver who is being treated for OSA should remain symptom free and agree to:Continue uninterrupted therapyUndergo yearly objective testing (e.g. MSLT or MWT)VACATED Former FMCSA GUIDELINESSleep Disorder TestsPSG in a controlled sleep laboratorySeverity (AHI)Mild : 5+ episodes/hourModerate : 15+ episodes/hourSevere : 30+ episodes/hourApnea/hypopnea >30 episodes/hr of sleep is considered a diagnosis of OSASelf-reported Sleepiness Surveys:NOTE: Self-reported sleepiness does NOT always correlate with objective testing (PSG). The driver may not perceive sleepiness as excessive or may be hesitant to disclose sleepiness.

OSA: Unofficial Guidance2006 Joint Task ForceACOEM, NSF, ACCP2008 Medical Expert PanelFMCSA Medical Review Board2012 Motor Carrier Safety Advisory Committee/Medical Review Board FMCSA has not chosen which guidelines to follow, but says that the only incorrect action is to do nothing.OSA: Unofficial Guidance(MEP, JTF, MRB/MCSAC)All address (with some differences)Criteria for OSA screening (BMI, neck circumference, medical DX, symptoms, etc.)Disqualifying vs. In-service (conditional) criteriaWaiting periodDiagnostic screeningTreatmentMonitoringAll agree to one year certification with OSAMembers of MEPSonia Ancoli-Israel, PhD :Professor of Psychiatry at the University of California San Diego School of Medicine, Director of the Sleep Disorders Clinicat the Veterans Affairs San Diego Healthcare System, Co-Director of the Laboratory for Sleep and Chronobiology at the UCSD GCRC, and Co-Director of the Education and Dissemination Unit of the VA VISN-22 Mental Illness Research, Education and Clinical Center (MIRECC). Charles Czeisler, PhD MD Baldino Professor of Sleep Medicine, Harvard Medical School and Senior Physician for the Division of Sleep Medicine at Brigham and Women's Hospital.Charles George, MD FRCPC Professor of Medicine at the University of Western Ontario in London, Canada and Director of the LHSC Sleep Disorders Laboratory. Christian Guilleminault, MD BiolD Professor of Psychiatry and Behavioral Sciences at the Stanford School of Medicine. Allan Pack, MB, ChB, PhD Professor of Medicine, and Neurology at the University of Pennsylvania School of Medicine and chief of the Division of Sleep Medicine and director of the Centerfor Sleep and Respiratory Neurobiology

MEP 2008Studies in passenger car drivers all show there is an increased risk of crashes in individuals with an AHI>30Some studies show that there is an increased risk in individuals who have less severe sleep apnea. Studies comparing individuals with excessive sleepiness to those who do not have sleepiness find that having an AHI20 episodes/hour is a risk factor for excessive sleepiness. (Pack, A.I., et al.,(2006). Risk factors for excessive sleepiness in older adults. Ann. Neurol. 59:898-904.)The expert panel thus believed that individuals with an AHI 20, until compliant with CPAPHave undergone surgery, < 3 months post-op, ORIndividuals non-compliant with treatment at any point, ORBMI >33, pending sleep study

Joint Task Force (JTF): 2008Made up members of American College of Chest PhysiciansAmerican College of Occupational and Environmental MedicineNational Sleep FoundationJoint Task ForceDisqualifyObserved/confessed excessive sleepinessMVA related to sleep unless evaluated sinceESS>/=16 or FOSQ30Joint Task ForceIn-service Qualification (3 months) if any one of the following 5 categories:History suggestive of OSA2 or more: BMI>35; BP new/uncontrolled/2+ medications;neck circumference >16Women or >17menESS>10Unconfirmed treatment compliancePrior PSG with AHI 6-29, AND: no MVA, No EDS, and