Donald Jacob, M.D. Medical Director - PowerPoint Presentation

Donald Jacob, M.D.Medical DirectorNiagara Frontier Transportation Authority 12th Annual FTA Drug and Alcohol ConferenceNew Orleans, LAApril 2017 Role of the Medical Review Officer Assistant Toni ClayMRO AssistantCahill Swift Role of the Medical Review Officer

WHAT IS AN MRO?MRO = Medical Review OfficerA Medical Review Officer is responsible for receiving and reviewing laboratory results generated by an employer's drug testing program and evaluating medical explanations for certain drug test results

MRO RESPONSIBILITIESIndependent and impartial gatekeeper and advocate for accuracy and integrity of the drug testing processReview custody and control forms (CCFs) check for problemsProvide feedback to employers, collectors and laboratories

MRO RESPONSIBILITIESConsult and report to Office of Drug and Alcohol Policy & Compliance (ODAPC)Determine if there is a legitimate medical explanation for laboratory confirmedpositive, adulterated, substituted or invalid drug test result

MRO RESPONSIBILITIESAct to investigate and correct problems with drug testing process and notify appropriate parties Ensure timely flow of test resultsProtect the confidentiality of the drug testing informationFollow all DOT regulations

49 CFR PART 40Phone AppDATIA Red BookSubscription

COMMUNICATION:MROSAP DERDonor Laboratory Collector ODAPC DOT Medical Examiner

REQUIREMENTS TO BE AN MRO49 CFR 40.121Licensed Physician (MD or DO)In a U.S., Canadian, or Mexican JurisdictionCannot be a nurse practitioner, physician’s assistant, or chiropractor

REQUIREMENTS TO BE AN MRODoes not need to be licensed in your stateMust receive qualification training by nationally recognized training organizationMust pass an examination administered by nationally recognized MRO certification board

REQUIREMENTS TO BE AN MROComplete requalification training every five (5) yearsPass another examination administered by nationally-recognized MRO certification board every five (5) years

MRO CERTIFICATION BOARDS:Medical Review Officer Certification Council (MROCC)American Association of Medical Review Officers (AAMRO)

VERIFY MRO CERTIFICATIONRequest copy of credentials (check expiration)MROCC = http://www.mrocc.com AAMRO = http://www.aamro.com

DRUG TEST SCAMS2010: Workplace Compliance, Inc. in North Carolina was issuing drug test reports without review by a certified MRO. Owner Michael Bennett, who was not a physician, was contacting donors and verifying laboratory positive drug test reports using a forged physician signature.

2009: Mobile Testing Services in Vermont was issuing drug test reports without having results reviewed by an MRO When the laboratory refused to process additional urine specimens because of unpaid bills, the company continued to issue negative reports without sending the urine for laboratory testing

2013: Advanced Substance Abuse Programs in California was fabricating negative drug test reports without sending specimens to a laboratory2015: Eastgate Laboratory Testing was forging an MRO’s signature on DOT urine drug test CCFs without having the tests reviewed by an MRO

Role of theMedical Review Officer Assistant Toni ClayMRO AssistantCahill Swift

What is an MRO-A MRO-A = Medical Review Officer Assistant A Medical Review Officer Assistant (Team Member) enhances the efficiency and integrity of the drug testing review process, as well as assists in protecting the rights of the donor during the collection process.A team member must understand all aspects of the regulations. The role of the MRO, the specimen collection process, chain of custody documentation and the process for reporting results.

MRO-A CertificationsNot A Regulated PositionAlthough the MRO-A or Team Member is NOT a regulated position, there is a test conducted to receive certificationThis certification is good for 3 yearsConducted only by MROCC

MRO-A ResponsibilitiesAssisting the MRO wherever possiblePrimary responsibility is processing and reporting laboratory negative test reports

Able to ConductReview Custody and Control Forms (CCFs) for problemsProvide feedback to employers, collectors and laboratoriesConsult and report to the Office of Drug and Alcohol Policy and Compliance (ODAPC)Investigate and correct problems with drug testing process and notify the appropriate partiesEnsure the timely flow of test resultsProtect the confidentiality of the drug testing information

Reviews CCF

Correctable Flaws (40.203)The MRO-A may request affidavits and follow-upIf the error is not corrected or documentation received, the MRO will cancel the testExamples of Correctable Flaws:Temperature box is not checked on the CCFThe collectors signature is missing from the certifying statement on the CCFThe employees signature is omitted and a refusal to sign is omitted from the remarks section

Fatal Flaws (40.199)Test is reviewed and canceled by the MROMRO-A may send out the documentation to the collector for Error Correction Training (ECT)Examples of Fatal FlawsNo collector name or signatureSpecimen numbers on the bottle and the CCF do not matchSpecimen bottle seal is broken or shows tampering and the split cannot be re-designatedThere is leakage or for another reason there is an insufficient amount of urine in the primary specimen and the split cannot be re-designated

FATAL FLAW – TEST CANCELLED

MRO-A Matches Report from Laboratory with Corresponding CCF

MRO-A can stamp MRO signature, complete Step 6 and transmit report to DER:

Laboratory Report MRO-A Action MRO-A Report Employer Action Negative Test:

Restrictions – MRO-A cannot:Gather medical information (can make contact with donor to speak to MRO)Determine if there is a legitimate medical explanation for laboratory confirmed positives, adulterated, substituted or invalid drug test resultsConduct the donor interviewCancel a test

49 CFR 40.17IT CAN SOMETIMES TAKE UP TO A WEEK FOR THE LAB TO SEND OUT A DRUG TEST REPORT Suppose an applicant for a safety-sensitive job takes a pre-employment drug test, but there is a significant delay in your receipt of the test result from an MRO or C/TPA. You must not assume that “no news is good news” and permit the applicant to perform safety-sensitive duties before receiving the result. This is a violation of the Department's regulations.

DILUTE URINE SPECIMENS

Laboratory Report MRO Action MRO Report Employer Action Negative Dilute

NON-NEGATIVE LABORATORY RESULTS

MRO REVIEW OF NON-NEGATIVE TESTSA laboratory positive urine drug test does not necessarily mean the donor is using drugs illegally or is a drug abuserThe donor must have an opportunity to provide a medical explanation for a test the laboratory reports as “positive”

MRO CONTACT WITH DONOR REQUIRED FOR:Positive - marijuana; cocaine; opiates; amphetamines; phencyclidine (PCP)InvalidAdulteratedSubstituted

POSITIVE DILUTE:Treated the same as POSITIVE testNo recollection required or authorized

MRO REVIEW – NON-NEGATIVE TESTSReview and match Copies 1 and 2 of CCF with laboratory test report (Copy 1 = certifying scientist copy)Make contact with donor either directly or by telephone and discuss test resultsAt least 3 contact attempts over 24-hours

Laboratory Positive

Certifying Scientist Copy 1 of CCF

POSITIVE REPORT TO DER:MRO must have a legible copy of Copy 1 of the CCF signed by Certifying Scientist from laboratory BEFORE releasing non-negative results to the DER X

MRO CONTACT WITH DONOR

MRO CONTACT WITH DONOR:MRO identifies himself to donor Confirm identity of donor (ID number)Mirandize the donor – ANYTHING you tell me, particularly if it related to safety, can be shared with employer, other evaluating physician, SAP, DOT agency or NTSB without the your consent

MRO CONTACT WITH DONOR:Explain that if donor declines to discuss result the laboratory result will be reported to the employer Explain that donor must undergo requested medical evaluations and failure to do so is the same as declining to discuss the results Explain that if prescribed medication poses safety risk donor will have 5 days AFTER MRO informs a third party to have prescribing physician contact the MRO to determine if medication can be changed to one that does not pose a safety risk

MRO CONTACT WITH DONOR:MRO informs donor of test result(s) Ask about prescribed medications“ Keeping in mind that this is not a confidential conversation, do you have any idea how [DRUG, ADULTERANT] could have shown up in your urine?”

POSITIVE REPORT TO DER:Donor must be evaluated, sent for treatment (at minimum must be sent for education) and cleared to return to safety sensitive duty by the SAP (substance abuse professional) X Cocaine Donor declined split specimen - has until Monday (7/17/14) at 3:00 PM to request split specimen

TIMELY FLOW OF TEST RESULTS40.167(b) – MRO must transmit to the DER on the same day or next business day: All verified positive test results Results requiring an immediate collection under direct observation Adulterated or substituted specimens and other refusals to test

49 CFR 40.167(b)(1)Direct telephone contact with the DER is the preferred method of immediate reportingFollow up the phone call with appropriate documentation

49 CFR 40.15(d) As an employer, you must not permit a service agent to act as your DER.

49 CFR 40.23(a)As an employer who receives a verified positive drug test result, you must IMMEDIATELY remove the employee involved from performing safety-sensitive functions You must take this action upon receiving the initial report of the verified positive result

49 CFR 40.23(a)Do not wait to receive the written report of the result from the MRODo not wait to receive the result of a split specimen if requested by the donor

PRESCRIPTION MEDICATIONS:If the donor documents a valid prescription to explain laboratory positive, MRO will report test as NEGATIVE MRO must inform employer of potential safety issue – employer must send donor for DOT medical evaluation and have examiner contact the MRO

Upcoming Tests for Synthetic OpioidsMost abusers of synthetic opioids will have a valid prescription from a doctorEmployer should inform employees that prescriptions over a certain age will not be considered valid (consult with MRO)

Laboratory Positive Tests Laboratory Report MRO Action MRO Report Employer Action

Always have at least TWO designated employer representatives with 24-hour availability Be sure both the DER and back up DER are not unavailable at the same time. Don’t leave the MRO without a DER contact!!

UNSUCCESSFUL MRO CONTACT MRO (or MRO-A) makes at least three attempts to contact donor at daytime and evening phone numbers spread evenly over 24 hours – if unsuccessful: Contact the DER and instruct the DER to contact the donor – document date & timeDER attempts to contact donor (document date and time of each attempt) - keep confidential

DER CONTACTS DONORAdvise donor that he or she must contact the MRO immediately Advise donor that if there is no contact with MRO within 72 hours the “report” will be released without an opportunity to discuss Inform MRO of date and time of contact

IF DER CANNOT CONTACT DONORDER must make a minimum of 3 attempts to contact donor spread evenly over 24 hours (document the date and time of all attempts) If no contact after 24 hours the DER may place the donor on“temporarily medically unqualified” status or on “medical leave.” Continue to try to instruct donor to contact MRO using phone, e-mail, voicemail and/or letter

MRO WILL REPORT RESULTS WITHOUT DONOR INTERVIEW IF:More than 72 hours have elapsed since the DER made contact with the donor The donor expressly declines to discuss the test results with the MRO Neither the MRO nor the DER have been able to contact the donor within 10 days of receiving the non-negative laboratory report

Problems Contacting Donor

Split Specimen Testing

SPLIT SPECIMEN TESTING:Donor has 72 hours after MRO contact to request split specimen MRO must send request for split testing immediately (cannot be contingent on payment) Cost $110 to $150 dollarsTested without regard to established cut-off levels Donor must be removed from safety sensitive duty pending results of split specimen

49 CFR 40.151(c)What are MROs prohibited from doing as part of the verification process?It is not your function to determine whether the employer should have directed that a test occur.

49 CFR 40.151(e)What are MROs prohibited from doing as part of the verification process?You must not verify a test negative based on information that a physician recommended that the employee use a drug listed in Schedule I of the Controlled Substances Act. (e.g. under a state law that purports to authorize such recommendations, such as the “medical marijuana” laws that some states have adopted).

Invalid Test

Invalid Result:

Substituted Specimen

SUBSTITUTED SPECIMEN:Creatinine concentration less than 2.0 mg/dL AND The specific gravity is less than or equal to 1.001 or greater than or equal to 1.020 Allow donor opportunity to provide medical explanation If no explanation report as: Refusal to Test – Specimen Substituted

SUBSTITUTED SPECIMEN:If donor can provide acceptable medical explanation within 5 days MRO reports test as: Cancelled MRO must inform ODAPC in writing of the basis for the determination

Adopted from Swotinsky, RB. 2015. The Medical Review Officer’s Manual. OEM Press

Adulterated Specimen

ADULTERATED SPECIMEN:MRO must contact donor If acceptable explanation – Test Cancelled, notify ODAPC No explanation – Refusal to Test: Specimen Adulterated

ADULTERATED SPECIMEN:pH less than 3 or greater than or equal to 11 Nitrite greater than or equal to 500 ug/mLChromium, surfactant, bleach, iodine, glutaraldehyde or other identified adulterant

MRO CANNOT:Reverse an adulterated test based on allegations that soap, bleach, or glutaraldehyde entered a specimen through physiologic means

Substituted or Adulterated Specimen:

Scenarios

Scenario #1: Driver Lynn Jones presents to the clinic for a random DOT urine drug collectionMs. Jones cannot provide a urine specimen and declines to drink any water during the three hour test periodThree hours after her first unsuccessful attempt, Ms. Jones has still not provided a urine sample and the test is terminated

The MRO should:A. Cancel the test because no sample was providedB. Report the test as positive because Ms . Jones refused to drink waterC. Have Ms. Jones return to the clinic the next day to try again to provide a specimenD. Send Ms. Jones for a medical evaluation

Donor cannot provide specimen within 3 hour limit: Collector notifies DER and documents failure to provide acceptable specimen in remarks section of CCFCCF sent to MRO – no specimen sent to lab (Collector’s printed name, signature and date must be in Step 4. Print donor’s name in Step 5 on copy 2 of CCF

Shy Bladder Medical EvaluationDER consults with MRO and directs donor to obtain within 5 days an evaluation by a licensed physician acceptable to the MRO

During the five days allowed for the shy bladder medical evaluation the employer should: A. Place the donor off work on medical leave B. Remove the donor from performing safety sensitive duty C. None of the above

Part 40 Q & A 07/06:Re: Removal from safety sensitive duty after shy bladderWe do not believe that it is appropriate for an employer to remove the employee from safety-sensitive duties until receiving the MRO’s verified resultTherefore, employers can apply for a stand down waiver that would permit the employee to be removed from safety sensitive duties when he or she does not provide an adequate amount of urine

Shy Bladder

Scenario #2At 9:00 AM the DER instructs rail operator, Sue Brown, to report to the collection facility for a random DOT urine drug test At 1:30 PM the collection facility calls to tell the DER that Ms. Brown has not yet shown up for her test

Scenario #2Who decides if Ms. Brown has refused the drug test?A. The MROB. The collectorC. The employer

49 CFR 40.61When a specific time for an employee's test has been scheduled, or the collection site is at the employee's work site, and the employee does not appear at the collection site at the scheduled time, the collector is instructed to contact the DER to determine the appropriate interval within which the DER has determined the employee is authorized to arrive.

49 CFR 40.191(a) As an employee, you have refused to take a drug test if you:(1) Fail to appear for any test (except a pre-employment test) within a reasonable time, as determined by the employer, consistent with applicable DOT agency regulations, after being directed to do so by the employer.

DER should establish time limit for presenting for drug testing after notification :Should inform the employees of the specified time limitShould inform employees that failure to present for the test within the specified time limit will be considered a refusal to test and treated as a positive test

Scenario #3Driver Sam Davis provides a DOT urine drug test that returns positive for cocaine When the MRO contacts him about the test, Mr. Davis states that the collector was processing two specimens at the same time and must have mixed his specimen up with the other donor

Scenario #3 The MRO should: A. Cancel the test and immediately send the donor for another DOT urine drug test under direct observation B. Report the test as negative and notify ODAPC C. Proceed with medical review and report the test as positive if there is no medical explanation D. Request the laboratory to perform genetic testing on the urine

49 CFR 40.151(b)What are MROs prohibited from doing as part of the verification process?It is not your function to make decisions about factual disputes between the employee and the collector concerning matters occurring at the collection site that are not reflected on the CCF (e.g., concerning allegations that the collector left the area or left open urine containers where other people could access them).

Scenario #4Driver Sarah Miller provides a post accident DOT urine drug test that returns positive for marijuana When the MRO contacts her about the test, Ms. Miller states that the accident only involved non-disabling damage to her bus with no injuries to anyone and no vehicle was towed from the scene.

Scenario #4The MRO should:A. Cancel the test because the accident does not meet FTA criteria for post-accident testingB. Report the test as negative and notify ODAPCC. Proceed with medical review and report the test as positive if there is no medical explanation

49 CFR 40.151(c)What are MROs prohibited from doing as part of the verification process?It is not your function to determine whether the employer should have directed that a test occur.

Scenario #5Your driver, Joe Smith, is called into the station for a random DOT urine drug collectionAfter the collection is started Mr. Smith claims that he has suddenly developed a medical emergency and leaves the station to go to the emergency roomEvaluation in the emergency room is negative for any serious condition and Mr. Smith is discharged two hours later

Part 40 Q&A - 07/2014If an employee leaves the collection facility prior to the testing process being completed, the collector must inform the employer. The employer must then determine whether the employee’s actions constitute a refusal to test.

Part 40 Q&A - 07/2014 To make this determination, the employer should consider the information documented on the CCF and the advice and information received from the collector and service agents , as well as any supporting information provided by the employee (copies of emergency department records, EMS records, police records, etc .)

Part 40 Q&A - 07/2014 The employer must document its decision, and the solid reasoning for the decision, in all collection site refusal determinations. Copies of these decisions, and the information relied on in making those decisions, must be maintained in accordance with 40.333 and the applicable modal recordkeeping requirements.