MRO

Specimen Adulterated

"A specimen that contains a substance that is not expected to be present in human urine, or contains a substance expected to be present but is at a concentration so high that it is not consistent with human urine." •Adulterant or sample condition must be specifically identified - (acidic, basic, gluteraldehyde, chromium, peroxide, a halogen, pyridine, etc.) •Quantitative adulteration parameters: - *Nitrite > 500 mcg/mL * - *pH <4 or >11.0*

Invalid Specimen

"A specimen that contains an unidentified adulterant or an unidentified interfering substance, has abnormal physical characteristics, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing or obtaining a valid drug test result." 1. Discuss result with certifying scientist, e.g., to identify potential interfering substances 2. Interview donor with procedure similar to positive test; MRO to ascertain if medication explanation exists, e.g., • Cipro® (ciprofloxin) Flagyl® (metronidazole) • Tolectin® (tolmentin) Outcome: Verified cancellation *• With medical explanation: no further testing required • Without medical explanation: re-collect under direct observation*

HHS Fit for Duty Guidance

"An MRO's decision to contact a donor's employer regarding fit for duty issues is not required or authorized by the HHS MRO Manual or the Mandatory Guidelines. Rather, an MRO's decision to contact an employer regarding safety issues related to a donor's valid prescription is subject to the MRO's voluntary choice and any obligations the MRO may have with the donor's employing agency." 2018 HHS MRO Manual, chapter 4.5.3 "Prescriptions

Reporting a Safety Concern: An Example

"Based upon information learned about the donor's medical history, test results, diagnoses, and/or treatment, MRO has reasonable concern about donor's ability to safely perform essential job functions. Strongly urge that donor undergo a fitness-for-duty evaluation by a qualified clinician. MRO will release pertinent information to examining health professional."

DOT urine Types Of Collections

"Normal" or Privacy collection • Donor goes into toilet enclosure with full privacy door & closes door; collector remains outside room Monitored collection • Collection takes place in multi-stall restroom; stall must have partial privacy door • Collector prepares one toilet/stall for use • Collector remains outside the closed stall door, but inside the restroom • "Monitor" can be opposite gender of donor if he/she is medical professional/paraprofessional Direct Observation or Witnessed collection • Limited circumstances • Observer must be in toilet enclosure with donor & observe urination • Observer must always be same gender as donor • Observer does not have to be the collector

Drug Test Interpretations (DOT/Federal)

"The Medical Review Officers (MROs) shall not accept the ingestion of a foodstuff allegedly containing THC or the ingestion of hemp oil allegedly containing THC as a legitimate medical explanation for the presence of delta-9 THC acid in a regulated industry donor specimen." "The Medical Review Officers (MROs) shall not accept a prescription, or the verbal or written recommendation of a physician for a Schedule I substance as a legitimate medical explanation for the presence of a Schedule

"Medical Miranda"

"The reason I am speaking to you personally is discuss the results of your drug test. There are a few things important for you to know: 1) If any further medical evaluation is needed you must comply with such a request and that failure to do so is the same as refusing to discuss the test result; 2) I am required to report to third parties *without your consent *drug test results or medical information affecting performance of safety-sensitive duties... You have the option of not discussing the matter with me if you choose. Do you have any questions at this point?" (Ref: 49 CFR 40.135) "The results of your drug test have been received and it is a ______ (positive, adulterated, substituted, invalid) test. The purpose of this interview is to provide you an opportunity to voluntarily share information with me that might explain this result, such as anything from your medical history, prescriptions, recent treatment or something in your diet. Based upon this information, I can make the best final determination of the result."

CCF Step 5

(On Copies 2-5 of CCF) • Donor's printed name, signature, DOB, telephone contact numbers, date of collection • If donor refuses to sign and complete Step 5, collector must note this in remarks section of Step 2 • Collector prints donor name in Step 5

CCF Step 5 a & b (Copy 1)

(a) completed by laboratory scientist on every non-negative result (positive, adulterated, substituted, rejected for testing, or invalid); (b) completed by laboratory for split specimen reconfirmation testing

Alcohol Concentration Units *NB slide*

*0.10% (weight per volume) is equal to: * •1 mg/mL (not routinely used except by some hospitals) •100 mg/dL (older literature and by some other parts of the world) •0.10 g/dL (not routinely used except by some hospitals) •1.0 g/L (older literature and by some other parts of the world)

Federal Drug Panel ("SAMHSA 5")

*Amphetamines* •Amphetamine •Methamphetamine •MDMA •MDA *Marijuana metabolites* *Cocaine* *Phencyclidine* *Opiates/Opioids* •Codeine •Morphine •6-AM (Heroin) •Hydrocodone •Hydromorphone •Oxycodone •Oxymorphone

Staff Training & Credentialing

*Collectors* Urine (MT) • Manuals, e.g., DOT • Training Course (classroom, distance, web) • Initial Proficiency Demonstration • Refresher Training every 5 years • Error Correction Training Breath Alcohol Technician (BAT) • Parallel to Urine Collector • Screening Test Technician (STT) • Alternative Matrices - (HAT?, SPIT?) *MRO * • Licensure - one state/province in No. Amer. • Qualification Training • Certification Examination • MROCC, AAMRO • Requalification training - every 5 years • Mandatory Recertification (HHS/DOT) *SAP* • Parallel process to MRO *MRO Assistants/Team Members* • No HHS/DOT standards • Training offered by ACOEM, DATIA, SAPAA • MROCC offers voluntary certification exam *Administrative staff* • Operate under authority of MRO • MRO responsible for quality/appropriateness of all actions

8. Interpret / "Verify" Findings

*MRO must VERIFY* laboratory-confirmed results as • *Negative* (with remarks if dilute) • *Positive * •* Canceled* (with remarks re reason) • *Refusal to Test *(with remarks, e.g., adulterated, substituted) MRO must simplify the complex, translating laboratory test and interview data into simple reportable terms

DOT 6 reason to do Direct Observation

*Required (determined by collection site)* *1. Specimen temperature out of range (90-100˚F)* • Immediate direct observation collection • Use new CCF and kit for witnessed re-collection • Record on CCF as collection 2 of 2, stating reason for direct observation • Send TOR specimen to laboratory; record as collection 1 of 2 *2. Tampering attempt identified * • Donor conduct or specimen qualities • Send suspect specimen to laboratory; record as collection 1 of 2 • Use new CCF and kit for witnessed re-collection • Record on CCF as collection 2 of 2, stating reason for direct observation NOTE: If 2nd specimen is not obtained (donor refuses or has "shy bladder), specimen 1 is discarded. No specimen(s) sent to the laboratory *Required (determined by MRO)* *3. Previous test canceled as "Invalid Result"- no medical explanation for specimen invalidity * *4. Previous test canceled because split was not available to reconfirm positive, adulterated or substituted result. * *5. Previous test was reported negative dilute with a creatinine of 2-5 mg/dL* NOTE: • For these circumstances, the MRO notifies the DER that a re-collection under direct observation is required • The Reason for Test is the same as the previous collection *Required (by employer)* 6. All DOT return to duty and follow-up tests as a result of a previous violation (positive, refusal to test) must be conducted as direct observation collections

HHS/DOT Mandatory Screening and Confirmation Cut-Offs (ng/mL)

*Screening * Marijuana metabolites (THCA) 50 Cocaine metabolites 150 Codeine/morphine 2000 Hydrocodone/hydromorphone 300 Oxycodone/oxymorphone 100 6-Acetylmorphine (heroin) 10 Phencyclidine (PCP) 25 Amphetamines 500 MDMA/MDA 500 *Confirmation* THCA 15 Benzoylecgonine 100 Morphine 2000 Codeine 2000 Hydrocodone 100 Hydromorphone 100 Oxycodone 100 Oxymorphone 100 6-Acetylmorphine (heroin) 10 PCP 25 Methamphetamine 250 Amphetamine 250 MDMA 250 MDA 250

MRO Review of non-Negative Results

*• Positive, Adulterated, Substituted, & Invalid • Must have CCF copy 1 with lab scientist's signature* • Review CCF Copy 2 (or equivalent) - copy with donor's signature • If employer has "stand-down" waiver, notify DER of laboratory result prior to contacting donor • Contact and interview donor

CONSORTIA & THIRD PARTY ADMINISTRATORS (TPA)

- A service agent that provides, or coordinates the provision of, a variety of drug and alcohol testing services to employers • May operate random testing programs • May assist with arrangements for other types of testing • May run "random pools" • May assist in follow-up testing (scheduling, etc.) • May receive and maintain drug & alcohol records for employer (including individual test results) • TPAs may provide MRO services • MRO performs duties independently and confidentiality • Physical and operational separation • Staff under direct supervision of MRO while performing MRO functions • Only MRO "interviews and verifies"

DOD

- Dept. of Defense

NIH - National Institutes for Health NIDA

- National Institute on Drug Abuse

NRC

- Nuclear Regulatory Commission

• HHS - Dept. of Health and Human Services SAMHSA NLCP

- Substance Abuse and Mental Health Services Administration - National Laboratory Certification Program

SAP definition

--A person who evaluates employees who have violated DOT drug and alcohol regulations and makes recommendations concerning substance abuse education/treatment, follow-up testing, and aftercare • Licensed Physician (MD or DO) Or Licensed or certified • Social Worker • Psychologist • Employee Assistance Professional • Drug and alcohol counselor certified by NAADAC, ICRC, NBCC • Marriage and Family Therapist Basic Knowledge/Experience • Diagnosis and treatment of drug- and alcohol-related disorders • SAP functions as they relate to employer interests in safety sensitive duties • 49 CFR Part 40 • DOT agency regulations • DOT SAP Guidelines SAP Qualification Training • Complete a training course that includes the following: • Background, rationale and coverage of the DOT testing programs • Part 40 and agency rules • Key DOT testing requirements • SAP prohibitions • SAP responsibilities • Reports & record-keeping • Complete an examination given by a nationally-recognized professional or training organization • Maintain training and examination documentation & provide it upon request: • to DOT agencies • to employers or service agents SAP Continuing Education • At least 12 CEUs every 3 years • Courses must include new technologies, interpretations, recent guidance, rule changes, and developments in SAP practice • Courses must include documented assessment of knowledge

What Does A.A. Do?

1. A.A. members share their experience with anyone seeking help with a drinking problem; they give person-to-person service or "sponsorship" to the alcoholic coming to A.A. from any source. 2. The A.A. program, set forth in our Twelve Steps, offers the alcoholic a way to develop a satisfying life without alcohol. 3. This program is discussed at A.A. group meetings. a. Open speaker meetings — open to alcoholics and nonalcoholics. (Attendance at an open A.A. meeting is the best way to learn what A.A. is, what it does, and what it does not do.) At speaker meetings, A.A. members "tell their stories." They describe their experiences with alcohol, how they came to A.A., and how their lives have changed as a result of Alcoholics Anonymous. b. Open discussion meetings — one member speaks briefly about his or her drinking experience, and then leads a discussion on A.A. recovery or any drinking-related problem anyone brings up. (Closed meetings are for A.A.s or anyone who may have a drinking problem.) c. Closed discussion meetings — conducted just as open discussions are, but for alcoholics or prospective A.A.s only. d. Step meetings (usually closed) — discussion of one of the Twelve Steps. e. A.A. members also take meetings into correctional and treatment facilities. f. A.A. members may be asked to conduct the informational meetings about A.A. as a part of A.S.A.P. (Alcohol Safety Action Project) and D.W.I. (Driving While Intoxicated) programs. These meetings about A.A. are not regular A.A. group meetings.

DOT Refusal to Test—Collection The refusal to test determination is made by the DER, not the MRO or the collector (DER - Designated Employer Representative)

1. Fail to remain at the testing site until the testing process is complete; 2. Fail to provide a urine specimen for any drug test required by DOT regulations 3. Fail to permit the direct observation of a specimen when required 4. Fail to cooperate with any part of the testing process, (e.g. failure to empty pockets or wash hands) 5. For an observed collection, fail to follow the observer's instructions to raise clothing above the waist, lower clothing and underpants, and to turn around 6. Possess or wear a prosthetic or other device that could be used to interfere with the collection process. 7. Admit specimen adulteration or substitution to the collector collector must - discard any specimen collected, - record circumstances on CCF, - discontinue collection process, - notify DER, - and distribute CCF copies(destroying Copy 1).

What A.A. Does Not Do

1. Furnish initial motivation for alcoholics to recover 2. Solicit members 3. Engage in or sponsor research 4. Keep attendance records or case histories 5. Join "councils" of social agencies 6. Follow up or try to control its members 7. Make medical or psychological diagnoses or prognoses 8. Provide drying-out or nursing services, hospitalization, drugs, or any medical or psychiatric treatment 9. Offer religious services or host/sponsor retreats. 10. Engage in education about alcohol 11. Provide housing, food, clothing, jobs, money, or any other welfare or social services 12. Provide domestic or vocational counseling 13. Accept any money for its services, or any contributions from non-A.A. sources 14. Provide letters of reference to parole boards, lawyers, court officials, social agencies, employers, etc.

MRO Responsibilities in Regulated Testing

1. Receive Results 2. Review Results 3. Interview 4. Record Pertinent Findings 5. Revel (in Donor Explanations) 6. Reconfirm Split Sample 7. Refer for Medical Evaluation 8. Interpret Findings 9. Report to Employer 10. Release Medical Information 11. Record keep 12. Assess Safety Risks & FFD

MRO Responsibilities (9 Rs - 2 Is - 1 A)

1. Receive Results 2. Review Results 3. Investigate / Inquire / Interview 4. Record Pertinent Findings 5. Revel (in Donor Explanations) 6. Reanalyze vs. Retest / Recollect 7. Refer for Medical Evaluation 8. Interpret / "Verify" Findings 9. Report to Employer 10. Release Medical Information 11. Recordkeep 12. Assess Safety Risks and FFD

THE TWELVE STEPS OF ALCOHOLICS ANONYMOUS

1. We admitted we were powerless over alcohol—that our lives had become unmanageable. 2. Came to believe that a Power greater than ourselves could restore us to sanity. 3. Made a decision to turn our will and our lives over to the care of God as we understood Him. 4. Made a searching and fearless moral inventory of ourselves. 5. Admitted to God, to ourselves, and to another human being the exact nature of our wrongs. 6. Were entirely ready to have God remove all these defects of character. 7. Humbly asked Him to remove our shortcomings. 8. Made a list of all persons we had harmed, and became willing to make amends to them all. 9. Made direct amends to such people wherever possible, except when to do so would injure them or others. 10. Continued to take personal inventory and when we were wrong promptly admitted it. 11. Sought through prayer and meditation to improve our conscious contact with God, as we understood Him, praying only for knowledge of His will for us and the power to carry that out. 12. Having had a spiritual awakening as the result of these Steps, we tried to carry this message to alcoholics, and to practice these principles in all our affairs.

Workplace Drug Testing - State Laws

14 states have mandatory drug testing laws that apply to employers' nonfederal workplace testing programs and procedures • May restrict or prohibit types of testing (e.g. random), specimens (e.g. oral fluid), testing panel (e.g. different cut-offs, opioids), specimen collection procedures (e.g. direct observation) • 10 states have voluntary workers compensation insurance premium reduction programs available to employers who have conforming drug/alcohol testing programs State laws on marijuana use fall into three basic categories • Medical marijuana (33 states & D.C.), personal (recreational) use (11 states & D.C.), low THC/CBD products (13 states) • Only 4 states prohibit marijuana use in any form (ID, KS,NE,SD) • 4 states (AR, OR, TX, WA) require MROs to report positive tests to State DMV on commercial drivers

Dilute Specimens

2 Criteria • SG >1.0010 but <1.0030 AND • Creatinine >2 mg/dL but <20 mg/dL

Washington State Interagency Opioid Guidelines

2007 • High risk of overdose in chronic users • "Yellow Flag" = *120 mg daily Morphine Equivalent Dose (MED)*; should refer to pain specialist 2015 • "No completely safe dose" • Risk 2X at 20-49 MED, 9X at 100 MED or more • Not recommended for LBP, fibromyalgia, etc.

Creatinine-Specific Gravity Summary

<20 mg/dL <1.0030 Dilute if BOTH criteria met Choose from appropriate category below --------------------------------------------------- >5 to 20 mg/dL *Negative dilute* Employer has option of one retest, not under direct observation 2 to 5 mg/dL *Negative dilute* Employer MUST retest under direct observation <2 mg/dL ≥1.0010 & <1.0200 ≥2 mg/dL ≤1.0010 *Invalid Invalid * Report as *Canceled (with or without valid explanation)* <2 mg/dL <1.0010 or ≥1.0200 *Substituted* if BOTH criteria met Report as Substituted

CCF Step 1

A. Employer info must have name of company and telephone & fax numbers of DER B. MRO info must have physician's name, address, phone/fax numbers C. Donor ID # SSN or other employee ID # For FMCSA test must use Commercial Driver's License (CDL)# and State of Issuance D. Testing Authority: HHS, NRC or DOT If DOT, must check DOT agency (FMCSA, FTA, FAA, etc. E. Reason for test: Pre-employment, random, post-accident, etc. • "Other"- used only for USCG periodic tests F. Drugs Tested for (drug test panel) • For DOT testing always check 5 drug panel (THC, COC, AMP, OPI, PCP) G. Collection site info must include physical location, phone & fax numbers

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Fentanyl

Abstral Actiq Duragesic Fentora Lazanda Onsolis Subsys

ACOEM Opioid Guideline - 2014

Acute or chronic opioid use NOT RECOMMENDED for patients who perform safety-sensitive jobs • "These jobs include operating motor vehicles, other modes of transportation, forklift driving, overhead crane operation, heavy equipment operation, sharps work (e.g., knives, box cutters, needles)... and tasks involving high levels of cognitive function and judgment." p. 11 Evidence Level = C: moderate confidence • crash risk increased >2x • dose-response relationship - maximum for opioid-naïve acute pain is 50 mg MED

RANDOM ALCOHOL TESTING

Adjustable annual rate (10-50%) based on random positive rate • Positives <.5 %; random rate 10% • Positives .5-1%; random rate 25% • Positives ≥1%; random rate 50% • Each DOT agency determines random rate for its regulated employers • Random alcohol testing must be conducted just before, during, or just after performance of safety-sensitive duties • Random testing must be unannounced and be conducted immediately after notification of employee. For 2020: FAA, FMCSA, FRA* FTA 10% FRA-Maintenance of Way 25%

Factors Influencing Illicit Drug Use

Age: peaks at 18-26 years, decreases with age Education: college graduates less likely to use Geography: varies significantly by region, state Type of drug: marijuana > amphetamines > opiates Gender: males > females Work-status: unemployed > part time > full time Occupation: highest in accommodations, food services, arts and entertainment Mental health status: mentally ill more likely to misuse substances

Sedatives

Alcohol -Beer -Wine -Spirits Benzodiazepines -Valium -Librium -Ativan -Xanax -Halcion -Restoril -Klonopin Benzo-Like -Ambien -Lunesta -Rohypnol Barbiturates -Phenobarbital -Secobarbital -Pentobarbital -Butabarbital -Amobarbital Barb-Like -Chloral Hydrate -Meprobamate -Glutethimide -SOMA

ALCOHOL TESTING DEVICES

Alcohol testing equipment • Certified by NHTSA • Listed on conforming products list (CPL) • Evidential breath testers (EBT) • Alcohol screening devices (ASD) • Saliva and breath Each device must have a Quality Assurance Plan (QAP) • Developed by EBT/ASD manufacturer • Approved by NHTSA • Include accuracy checks, tolerance ranges, maintenance requirements, quality control

ADA (Americans with Disabilities Act) and Substance Abuse

Alcoholism can be a protected disability. History of drug addiction can be a protected disability. Being under treatment for substance abuse can be a protected disability. However, if a donor tests positive for any controlled substance that is not medically authorized, (s)he is automatically excluded from protection under ADA. The ADA does *not* interfere with an employer taking appropriate action for alcohol or drug abuse/impairment on the job. Testing: Alcohol: As a medical test, pre-employment alcohol testing is prohibited by ADA; can only be performed after a job offer has been made. Drug tests are not medical examinations under ADA and thus are not subject to the same restrictions as other employment physicals. Drugs: The ADA does not impact an employer's ability to perform drug testing for applicants or employees

Laboratory Reporting to MRO

All test results come from laboratory to MRO *• Cannot go to TPA or employer* • Negative results can be reported electronically without a CCF copy • Laboratory may report quantitative results on all positive results • Rejected for testing, Adulterated, & Substituted results must include standard explanatory remarks

Acronyms -Professionals

BAT -Breath Alcohol Technician DER -Designated Employer Representative MRO -Medical Review Officer MRO-A -Medical Review Officer Assistant SAP -Substance Abuse Professional STT -Screening Test Technician C/TPA -Consortium/Third Party Administrator PIE -Public Interest Exclusion

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Barbiturates -Phenobarbital

Bellergal-S Donnatal Hysophen Mysoline (Primidone)

Cocaine

Benzoylecgonine and Ecgonine Methyl Ester are major metabolites. Norcocaine is a minor metabolite half-life of Benzoylecgonine is much longer - can be detected for days after use Herbal teas (e.g. Health Inca Tea, "HIT," Mate de Coca)

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Buprenorphine

Burprenex Butrans Suboxone Zubsolv

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Barbiturates -Butabarbital -Butalbital

Butisol Ascomp with codeine Esgic and Esgic-Plus Fioricet Fiorinal Phrenilin Zebutal

Commercial Driver Drug Tests

CDME Drug Tests • Not "Official" DOT test • Drug test not required • Done at discretion of medical examiner • Does not have to follow DOT drug test protocols: - Drug (i.e., broader panels) - Matrix (e.g., hair, blood) - Labs not NLCP certified DOT Drug Tests • Official "DOT drug test" • Mandatory • Fixed panel of drugs • Must follow all DOT drug testing protocols

Drugs Not Currently Included in HHS Panel

Cannabinomimetics, for example • K2 and Spice etc Methcathinone derivatives ("Bath Salts") • Methylenedioxypyrovalerone (MDPV) • Mephedrone • Methylone • Pyrovalerone Fentanyls • Fentanyl and sufentanil (prescribed) • Carfentanil • Alpha-methylfentanyl • Butyrl-fentanyl • 3-Furanyl fentany Other synthetic opiates

EFFECTS OF A CANCELED TEST

Cannot treat as a violation of the DOT rules Cannot order another collection except when: • Invalid Result- no medical explanation • Failure to Reconfirm—Split specimen not available • Negative result is needed on pre-employment, return to duty or follow-up test Cannot count toward compliance with random testing percentage Cannot be basis for requiring a test under company policy

Synthetic Cathinones/Phenylethylamines (Bath Salts, NBOMe, etc) [stimulants]

Chemicals • Methylenedioxypyrovalerone (MDPV) • Methylone • Mephedrone • 2CI-NBOMe Route of Administration • Swallowed • Snorted • Smoked • Injected Psychoactive effects similar to amphetamines-many also have a hallucinogenic component Symptoms • Headaches • Heart palpations • Nausea • Hallucinations • Paranoia • Panic Attacks • Violent Behavior

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: Hydrocodone

Co-Gesic Hycet Hydromet Lorcet Lortab Norco Reprexain Rezira TussiCaps Tussigon Tussionex Vicodin Vicoprofen Zutripro Zydone

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Cocaine

Cocaine hydrochloride, solution or viscous, used as a vasoconstrictive anesthetic • e.g., in otolaryngology, ophthalmology, and dentistry. TAC • (tetracaine, adrenaline, and cocaine mixture). • Used in some emergency rooms as a topical anesthetic, e.g., before suturing. Brompton's Cocktail • (contains an opiate - usually morphine - and cocaine and/or a phenothiazine); • used in past years, rarely now, for pain control of the terminally ill.

Opiate Metabolism

Codeine --> Norcodeine --> Morphine Heroin --> 6-Acetylmorphine --> Morphine Morphine --> Normorphine Morphine--> Morphine Glucuronide

DOT urine Collection Process

Collector checks donor photo ID and explains collection process • Can refer to collection procedures printed on back of Copy 5 of CCF Donor instructed to remove outdoor clothing • Collector checks pockets; donor must leave all hand-carried items outsider toilet enclosure Collector completes Step 1 of CCF Collector presents collection kit (s) Collector instructs donor to wash hands Collector unwraps collection container and provides it to donor, instructing donor to enter toilet enclosure, close door, and provide at least 45 mL of urine Donor comes out of toilet enclosure and presents specimen to collector Collector checks specimen temperature within 4 minutes; checks appearance and volume; collector completes Step 2 of CCF • Any discrepancies or atypical characteristics must be noted in remarks section Collector unwraps/opens specimen bottles and pours specimen into bottles; collector closes bottles and applies bottle seals; collector dates each seal. Donor initials each seal; donor may wash hands; donor completes Step 5 Collector completes Step 4 Collector puts CCF and specimen bottles in plastic bag and seals bag. Collector gives donor Copy 5 of CCF; collection is complete Collector faxes or emails CCF copies 2 and 4 to MRO and employer

CCF Step 2

Collector must check temperature box and must check "split" or "none provided" (shy bladder) • "Single" should only be checked if "suspect" specimen is less than 45 mL and is being sent to laboratory as first of two specimens collected Remarks required for any atypical collection circumstance, including an observed collection • Shy bladder notations (attempts, fluids offered, etc.) • Unusual characteristics of specimen or collection

Multiple Specimens from 1 Test Event

Collector should have labeled each of 2 CCFs • "Specimen 1 of 2" or "Specimen 2 of 2" • Both specimens are evaluated and reported as a single test event • If either specimen is positive, adulterated, or substituted, then *all* verified results are reported • If first specimen negative, wait for second. If first specimen is non-negative, report before get second.

CCF Step 7

Completed by MRO for split specimen reconfirmation verification

Federal Urine Drug Testing CCF

Current version of federal CCF expires August 2020 • Proposed new federal CCF will be used for urine specimen and/or oral fluid specimen collections • CCF is available in paper and electronic formats Federal CCF is used ONLY for collections performed for federallymandated testing programs (DOT, HHS, NRC) Five copies • Only one copy (Copy 1) is sent with specimen to the laboratory • Copies 2 & 4 should be faxed or scanned and emailed to MRO & Employer • MRO must receive and review CCF Copy 2 before reporting any test result to the employer CCF is completed and signed by collector and donor as part of specimen collection process

CCF

Custody control form

MRO Reporting of Safety Concerns

DHHS Mandatory Guidelines • If MRO identifies safety / fit-for-duty concerns, may report them by choice without agency authority DOT - 40.135 • MRO has duty to identify specific concerns • Must report verified negative immediately • If RX, must wait 5 days to allow treating physician to consult with MRO • After 5 days, *must* report safety concern

DOT MRO Reporting of Safety Issues

DOT has required MROs to disclose medical disqualifications or safety risks to DER Release of "medical information" required by MRO if • MRO believes donor is medically unqualified for a DOT safety-sensitive position • MRO believes that there is a "safety-risk" associated with the donor's performance of safety-sensitive duties MRO must ensure confidential transmission of test results MRO may only release test result information to DER (or TPA), donor, or SAP **Note that ACOEM Code of Ethical Conduct opposes release of medical diagnoses, findings, treatments.

CONFIDENTIALITY & RELEASE OF INFORMATION

DOT rules prohibit release of information to a "third party" without donor's written consent • Exceptions: employer, SAP, DOT agency, TPA Employer can release information in legal proceeding initiated by employee or when employee's performance of safety-sensitive duties is the issue • MRO or TPA must release information to the employer for the above purposes Donor is always entitled to information concerning his/her test result (MRO must provide information within 10 days of employee's written request)

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Meperidine

Demerol

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Hydromorphone

Dilaudid Exalgo Hydromorphone can also be produced by large amounts of morphine through a minor metabolic pathway

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: Methadone

Dolophine Methadose

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Morphine

Donnagel-PG Infantol Pink Kaodene with paregoric Quiagel PG Apokyn Astramorph Avinza Brompton's Cocktail (see "Cocaine" above) DepoDur Duramorph Embeda Infumorph Kadian MS Contin

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Marijuana

Dronabinol Marinol Marijuana More than 20 states and the District of Columbia allow use of marijuana for certain medical conditions under a physician's direction. These laws do not supersede DOT's position that marijuana is not an acceptable medical explanation for a positive result.

EAP

Employee Assistance Programs

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Oxycodone

Endocet Endodan Oxecta Oxycontin Percocet Percodan Roxicet Roxicodone Roxilox Tylox

Thirteen circumstances define refusal to test

Failure to: 1. Appear at the collection site (including within a reasonable time as defined by the employer) 2. Remain at the collection site until the process is complete 3. Provide a specimen (or attempt to do so) 4. Permit direct observation collection when required by the rule 5. Provide adequate specimen volume (without medical explanation) 6. Undergo a medical examination when directed 7. Cooperate with any part of the collection process 8. Submit to a re-collection as required 9. Follow the observer's instructions to raise clothing above the waist, lower clothing and underpants, and to turn around to permit the observer to determine if donor is wearing a prosthetic or other device that could be used to interfere with the collection process 10. Sign Step 2 of Alcohol Test Form 11. Possess or wear a prosthetic or other device that could be used to interfere with the collection process. 12. Admit to the collector or MRO that he/she adulterated or substituted the specimen 13. Submission of a specimen that the MRO determines is adulterated or substituted

DHHS Changes - October 1, 2017

Federal agencies authorized to test for opioids: • Hydrocodone, hydromorphone • Oxycodone, oxymorphone • Adulterated Specimen: pH <3 --> pH <4) • Stop testing for MDEA • MROs may report safety concerns (optional) • MROs must receive training before implementation

DHHS Changes - 2020+

Federal hair testing: • Mandated by Congress in 2015 • F.A.S.T. Act* to implement proving to be SLOW • Proposed standards were approved by DTAB; OMB review delayed * Fixing America's Surface Transportation Act (FAST)

DHHS Changes - October 25, 2019

Federal oral fluid testing standards published: • Offers a flexible alternative option to urine • FDA/HHS approved collection devices • Analysis at DHHS-certified laboratories • Split specimen collection • Estimate 12-18 months for labs to establish implementation protocols • DOT must determine whether to follow and if so, publish own proposed regulations (late 2020?)

Is Medical Marijuana an Acceptable Medical Explanation?

Federally Regulated • DHHS/DOT: Schedule 1 substance *not* acceptable Non-Federally Regulated • MROCC/AAMRO: Determined by employer policy • ACOEM/AAOHN: MRO should report as positive, with explanation; employer to make determination • ACOEM MRO Section: "may determine whether medical facts corroborate valid medical marijuana use." KP: problematic in brief telephone interview

EMPLOYER RECORD KEEPING REQUIREMENTS

Five Years • Verified positive drug tests; alcohol tests 0.04 or greater • Refusals, Adulterated, Substituted test documentation • SAP reports • Follow-up testing schedule & test results Three Years • Previous employer drug and alcohol test results One Year • Negative & canceled drug and alcohol test results Service Agent (MRO, TPA) may keep these records for employers

SAP Follow-up Evaluation Report: Compliant Employee

Follow-up evaluation letter for employee who demonstrated successful compliance must contain: • Date of follow-up evaluation interview • Name of practice(s) or service(s) providing the recommended education and/or treatment; • Inclusive dates of employee's program participation; • Clinical characterization of employee's program participation; • Follow-up testing plan; • Employee's continuing care needs, as appropriate, with specific treatment, aftercare, and/or support group services recommendations

d- and l- Methamphetamine Interpretation

For Vick's Inhaler™, d and l isomer characterization reveals: • Large percentage of l-methamphetamine and little or no d-methamphetamine • *l-methamphetamine must be at least 80%* Selegiline gives more equal amounts of l-amphetamine and l-methamphetamine - 80% rule also applies.

Components of a Comprehensive Drug-Free Workplace Program

Formal Written Policy Employee Assistance Program Supervisor Training Employee Education Methods for Detecting Illicit Drug Users (i.e., drug testing)

Opiates/Opioids Examples

Heroin Morphine Codeine Oxycodone Oxymorphone Hydrocodone Hydromorphone • Buprenorphine • Butorphanol • Dihydrocodeine • Diphenoxylate • Fentanyl • Meperidine • Methadone • Sufentanil • Tramadol

Opioid Metabolism Simplified

Hydrocodone --> Hydromorphone Oxycodone --> Oxymorphone

EXAM

I SUBSTANCE ABUSE (5%) II. REGULATORY ISSUES AND MRO ROLE (50%) III. TOXICOLOGY, PHARMACOLOGY AND LABORATORY ISSUES (20%) IV. CLINICAL ASPECTS (10%) V. COLLECTIONS AND PROCEDURES (15%)

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Amphetamines -amphetamine -methamphetamine

I-methamphetamine • Vicks Inhaler and generic equivalents I-amphetamine and l-methamphetamine • Selegiline (Eldepryl and Ensam patch) l-amphetamine and d-amphetamine • Adderall (approximately 3:1 mixture of d- to to l- amphetamine) d-amphetamine • Dexedrine • Paremyd ophthalmic (hydroxyampohetamine) • Procentra • Vyvanase (lisdexamfetamine dimesylate) d-amphetamine and d-methamphetamine • Didrex (benzphetamine) • Desoxyn contains d-methamphetamine. It is metabolized to d-amphetamine

Fatal Flaws

Identified by the laboratory and the specimen is rejected for testing • The specimen ID numbers on the CCF and bottle do not match • Both collector signature and collector printed name are missing • Bottle seal is broken, absent, or shows evidence of tampering • Neither primary nor split specimen has at least 30 ml of urine • The specimen was received at the laboratory without a CCF • The CCF was received at the laboratory without a specimen • The collector performed two separate collections using one CCF

Negative Dilute Specimen

If creatinine 2-5 mg/dL (under DOT), • Report as Negative Dilute • Notify DER that *collection required (under direct observation)* If creatinine >5 but <20 mg/dL • Report as Negative dilute • Notify DER that another collection is authorized (not direct observation) • Employer must apply policy equally to all employees, but may treat types of tests differently • Employer must accept result of second test

SPLIT SPECIMEN--MRO PROCESSING

Inform donor of opportunity to have split analyzed on verified-positive, adulterated or substituted test • No split specimen reconfirmation offered for invalid specimen result Process request for split analysis (*72 hr. window for donor decision*) Provide written request to laboratory • Include specimen ID#, drug(s), adulterant or substitution findings to be reconfirmed Do not delay reporting of verified result pending split specimen decision or result MRO cannot require "up-front" payment for split analysis from donor or employer

Creatinine: <20 mg/dL Specific Gravity: <1.0030

Interpretation: Dilute if BOTH criteria met MRO Action: Could be - retest under direct observation, - cancelled - invalid depending on values

Creatinine: <2 mg/dL with Specific Gravity: ≥1.0010 & <1.0200 Creatinine: ≥2 mg/dLwith Specific Gravity: ≤1.0010

Interpretation: Invalid MRO Action: Report as Canceled (with or without valid explanation)

Creatinine: 2 to 5 mg/dL Specific Gravity: doesn't matter?

Interpretation: Negative dilute MRO Action: Employer MUST retest under direct observation

Creatinine: >5 to 20 mg/dL Specific Gravity: doesn't matter?

Interpretation: Negative dilute MRO Action: Employer has option of one retest, not under direct observation

Creatinine: <2 mg/dL Specific Gravity: <1.0010 or ≥1.0200

Interpretation: Substituted if BOTH criteria met MRO Action: Report as Substituted

Alternative Specimens: Hair Collection

Intoxication minutes to hours • Impairment " " " • Under influence " " " • Blood minutes to days • Breath minutes to ? • Oral fluid (saliva) " " " • Urine hours to days • Sweat weeks *• Hair days to months * • Nails days to months

Cocaine Route of Administration Profiles

Intranasal • Onset 30 seconds to 2 minutes • Post drug dysphoric State Intravenous • Onset 15 seconds or less • Peak in 3-5 minutes • Duration 15-20 minutes Smoking • Onset in 10 seconds or less • Peak in 3-5 minutes • Duration of high 15 minutes

Hair Testing *Confirmation* Cut-Offs (pg/mg)

Lab. A Confirmation Cut-Offs (pg/mg) Marijuana (THCA) 0.1 Amphetamines (includes amphetamine, methamphetamine, MDMA and MDA) 300 Cocaine/Metabolites (includes benzoylecgonine, cocaine, cocaethylene, and norcocaine) 300 Opiates/Opioids (includes morphine, codeine, MAM, hydrocodone, hydromorphone, oxycodone, and oxymorphone 300 PCP 300 Lab. B Confirmation Cut-Offs (pg/mg) Marijuana (THCA) 0.1 Amphetamines (includes amphetamine, methamphetamine, MDMA and MDA) 500 Cocaine/Metabolites (cocaine 50 pg/mg, others at 300) 300 Opiates/Opioids (includes morphine, codeine, MAM, hydrocodone, hydromorphone, oxycodone, and oxymorphone 200 PCP 300

Hair Testing: *Screening* Cut-Offs (pg/mg)

Lab. A Screening Cut-offs (pg/mg hair) Marijuana (THC) 1 Amphetamines 300 Cocaine/Metabolites 300 Opiates 300 Opiates/Opioids 500 PCP 300 Lab. B Screening Cut-offs (pg/mg hair) Marijuana (THC) 2 Amphetamines 500 Cocaine/Metabolites 500 Opiates, Hydrocodone and Hydromorphone 200 Oxycodone/Oxymorphone 200 PCP 300

MRO DISCLOSURE OF MEDICAL INFORMATION

MRO *must* report medical information learned in the verification process in the following circumstances: • Employee could be medically unqualified under a DOT regulation • Continued performance of safety-sensitive duties by the employee is likely to pose a significant safety risk Parties to whom MRO may release medical information include: • *Employer, physician, SAP, DOT agency, State Safety agency, NTSB (Natl. Transportation Safety Board)*

How MRO should report lab result: LAB. REPORT: Split Reconfirmed

MRO PROCEDURE: Notify donor of reconfirmation result MRO REPORT: Reconfirmed

How MRO should report lab result: LAB. REPORT: Positive (Drug(s) specified) - Dilute Laboratory must report numerical values for Creatinine & SG

MRO PROCEDURE: Review Copy 1 & 2 of CCF Conduct donor interview MRO REPORT: Negative w Dilute Remark Positive for XYZ drug(s) w Dilute Remark Canceled w Remark (CCF)

How MRO should report lab result: LAB. REPORT: Invalid w Remarks

MRO PROCEDURE: - Discuss result with certifying scientist to determine if specimen should be tested at another laboratory - Conduct donor interview if specimen not being sent for further testing MRO REPORT: Refusal to Test w Remarks (admits to adulterating or substituting specimen) Canceled w Remarks: -CCF error - No Medical Explanation (recollection under direct observation required) - Valid Medical explanation (no recollection unless negative is needed) -Employee admitted drug use

How MRO should report lab result: LAB. REPORT: Split Failure to Reconfirm (1) Drugs not detected (2) Adulteration criteria not met (3) Substitution criteria not met (4) Split specimen Invalid (5) Split specimen adulterated or substituted (6) Split specimen not available for testing

MRO PROCEDURE: Donor interview required only for #5 MRO REPORT: Canceled w Remark; Also notify DOT ODAP Dilute w Remark (if creatinine 2-5 mg/dL) -Immediate recollection under direct observation required for #4 and #6. -immediate recollection under direct observation also required if #3 split is dilute with Creatinine 2-5. Refusal to Test—Adulterated or Substituted (#5 only)

How MRO should report lab result: LAB. REPORT: Substituted w Remarks Substituted w Confirmatory values for Creatinine & SG

MRO PROCEDURE: Review Copy 1 & 2 of CCF Conduct Donor Interview MRO REPORT: Refusal to Test w Remarks Canceled w Remarks - CCF or Valid Medical Explanation (report to ODAPC) [Office of Drug & Alcohol Policy & Compliance]

How MRO should report lab result: LAB. REPORT: Adulterated w Remarks Adulterated w Adulterant noted & confirmatory values (when applicable)

MRO PROCEDURE: Review Copy 1 & 2 of CCF Conduct donor Interview MRO REPORT: Refusal to Test w Remarks Canceled w Remarks (medical explanation)

How MRO should report lab result: LAB. REPORT: Rejected for Testing w Remark

MRO PROCEDURE: Review Copy 1 & Copy 2 of CCF MRO REPORT: Canceled w Remark (CCF)

How MRO should report lab result: LAB. REPORT: Positive (Drug(s) specified)

MRO PROCEDURE: Review Copy 1 & Copy 2 of CCF Conduct donor interview MRO REPORT: Negative Positive for specific drug(s) Canceled w Remark (CCF)

How MRO should report lab result: LAB. REPORT: Negative

MRO PROCEDURE: Review Copy 2 of CCF MRO REPORT: Negative Canceled w Remark (CCF)

How MRO should report lab result: LAB. REPORT: Negative - Dilute (creatinine 5-20) Laboratory must report numerical values for Creatinine & SG

MRO PROCEDURE: Review Creatinine & SG values on laboratory report Review Copy 2 of CCF MRO REPORT: Negative w Remark - Dilute, *may* recollect Negative w Remark - Dilute, must recollect Canceled w Remark (CCF)

How MRO should report lab result: LAB. REPORT: Negative - Dilute (creatinine 2-5) Laboratory must report numerical values for Creatinine & SG

MRO PROCEDURE: Review Creatinine & SG values on laboratory report Review Copy 2 of CCF MRO REPORT: Negative w Remark - Dilute, *must* recollect Canceled w Remark (CCF

Special circumstance: Multiple non-negative results on one specimen

MRO PROCESS: Donor interview MRO REPORT: Report positive and refusal to test results on the specimen Do not report invalid (cancelled) when positive and/or adulteration/substitution are verified

Special circumstance: Multiple results for a testing event (2 specimens collected and tested)

MRO PROCESS: If 1st specimen is negative and 2nd specimen result has not been received, MRO should hold negative result until 2nd specimen result is received and reviewed If 1st specimen is verified non-negative, it should be reported without wait for the 2ndspecimen result MRO REPORT: Negative — if both specimens were verified negative Positive and/or Refusal to Test if either specimen was verified as non-negative If both specimens are verified as non-negative report all non-negative results

Special circumstance: Second Invalid result for a different reason than that reported for first specimen

MRO PROCESS: Review CCF to ensure that recollection was directly observed In collection was observed, direct DER to conduct an immediate recollection under direct observation—No donor interview If recollection was NOT observed, do not report test result and again instruct DER that an immediate recollection under direct observation is required MRO REPORT: No test result report

Special circumstance: Second Invalid result for same reason as first invalid specimen

MRO PROCESS: Review CCF to ensure that recollection was directly observed If recollection was NOT observed, do not report test result and again instruct DER that an immediate recollection under direct observation is required MRO REPORT: If observed, Cancelled Test — No recollection -If a negative result is needed (pre-employment/RTD/FU) follow process for determining if there is clinical evidence of drug abuse

Special circumstance: Invalid specimen report with confirmed positive, adulterated or substituted test

MRO PROCESS: Review Copy 1 & 2 of CCF Conduct donor interview based on positive/adulterated or substituted finding MRO REPORT: If verified as positive or refusal to test DO NOT report Invalid Only report Invalid if split specimen fails to reconfirm

10. Release Medical Information

MRO must release medical information learned as part of verification process to third parties without donor's consent if • Information likely to result in employee being medically unqualified under an applicable DOT regulation • DOT "if continued performance in safety-sensitive function likely poses significant safety risk" Report to employer, health care provider determining medical qualifications, or DOT agency

MRO Function •

MRO role is as "gatekeeper" • After review and interpretation of all available information, the MRO makes a "verification" e.g., laboratory Confirmed Positive becomes a *Verified negative, positive, cancelled or refusal to test*

MRO Recordkeeping

Maintain all CCF Copy 2 with signature or stamp with initials • Negatives- 1 year • Non-Negatives- 5 years • Retain all non-negative result documentation 5 yr. • Drug test results should be separated from patient medical chart because of confidentiality concerns • Transfer records upon employer's request to new MRO

Psychedelics/Hallucinogens

Marijuana (THC) Phencyclidine (PCP) MDMA (Ecstasy)/MDEA • Cannabinomimetics (K2, Spice) • LSD • Ketamine • Psilocybin (Mushrooms) • Mescaline (Peyote)

HHS Oral Fluid *Confirmation* Cut-Offs (ng/ml)

Marijuana (THC) 2 Cocaine 8 Benzoylecgonine 8 Codeine 15 Morphine 15 Hydrocodone 15 Hydromorphone 15 Oxycodone 15 Oxymorphone 15 6-Acetylmorphine (Heroin) 2 Phencyclidine 10 Methamphetamine 25 Amphetamine 25 MDMA 25 MDA 25

HHS Oral Fluid *Screening* Cut-Offs (ng/ml)

Marijuana (THC) 4 Cocaine/Benzoylecgonine 15 Codeine/Morphine 30 Hydrocodone/Hydromorphone 30 Oxycodone/Oxymorphone 30 6-Acetylmorphine (Heroin) 4 Phencyclidine 10 Amphetamines/Methamphetamine 50 MDMA/MDA 50

Medication Assisted Treatment (MAT)

Methadone • Full agonist Naltrexone • Antagonist Buprenorphine • Mixed agonist/antagonist Drugs combining buprenorphine + naloxone • Suboxone (sublingual film) • Zubsolv (tablets) • Bunavail (buccal film)

SAP Initial Evaluation Report

Must be on SAP's own letterhead signed and dated by the SAP, and must contain the following: • Employee's name and SSN; • Employer's name and address; • Reason for the assessment (specific violation of DOT regulations and violation date); • Date(s) of the assessment; • SAP's education and/or treatment recommendation; • SAP's telephone number. In making the referral, SAPs cannot: • Refer to own private practice • Refer to person or organization paying them • Refer to person or organization in which they have a financial interest or association 4 exceptions: • Public agency • Provided by employer or employer contract • Health insurance • Sole provider reasonably accessible service

SAP Report: Non-Compliant Employee

Must contain: • Date of initial evaluation and summary of recommended treatment • Date(s) of the first follow-up evaluation; • Date(s) of any further follow-up evaluation the SAP has scheduled; • SAP's clinical reasons for determining that the employee has not demonstrated successful compliance;

NEGATIVE RESULTS

Negative Needed to hire or return to safety-sensitive duty Negative - Dilute remark Laboratory must provide numerical creatinine value Creatinine 2-5 mg/dL - Recollection of specimen required under direct observation Creatinine >5 <20 mg/dL - Employer may direct donor to submit another specimen (no direct observation) - Employer must accept result of second test; cannot recollect again even if second test is again dilute. No MRO interview required

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Barbiturates -Pentobarbital

Nembutal

CCF Step 3

No CCF entry required; instructions for sealing, initialing and dating bottle seals

Rehabilitation

Objective: To permit an employee who has violated drug & alcohol rules or who has been identified as having a substance abuse problem to re-enter the work force, while protecting the employer and the public by securing documentation that the employee is rehabilitated and no longer using or abusing prohibited substances • DOT regulations DO NOT mandate that an employer provide treatment for an employee who tests positive, but State laws may impose a requirement for employers to offer treatment in lieu of termination. Individual Treatment Plan: • Medical detoxification • Outpatient psychoeducation • Outpatient relapse prevention • Residential therapeutic treatment • Family therapy • Self-Help support Systems • 12 Step programs (e.g., AA, NA, CA, MA) • Rational Recovery or Secular Organizations for Sobriety (SOS) • Toxicology screens/abstinence monitoring

HHS Mandatory Guidelines for Oral Fluid Drug Testing (OFMG)

Oct 25, 2019--The Department of Health and Human Services (HHS) published the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG). Jan 1, 2020--Effective date; however, Federal agencies will not be able to conduct oral fluid drug testing until HHS has approved laboratories for oral fluid drug testing in accordance with the OFMG. Expected to take 12-18 months before laboratories are certified for OF testing The OFMG are based on the proposed OFMG published in May 2015. The OFMG allow federal executive branch agencies to collect and test oral fluid specimens as part of their drug testing programs. First time since the Executive Order 12564 in 1986, requiring drug testing of federal employees, that a specimen other than urine can be used federal agencies' testing programs.

Canceled Tests

Only MRO can cancel a drug test MRO must cancel tests that: • Are rejected by laboratory for a fatal flaw • Are reported as "Invalid" • Fail to reconfirm on split analysis • Are "shy bladder" with medical explanation • Have a correctable flaw, but no statement of correction could be obtained

Changing A Verified Result

Only an MRO can change a verified result, e.g., • re-opening the verification process when a donor was not interviewed • split specimen result did not reconfirm • lab or MRO error discovered after the result verification • within 60 days the MRO receives new information that could not have been provided during the verification process (if this occurs after 60 days, the MRO must contact DOT before changing the result)

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Oxymorphone

Opana

-codone vs -morphone

Parent compound eliminated more quickly than metabolites • A person taking oxycodone could have drug test positive only for oxymorphone • Someone taking hydrocodone could have drug test positive only for hydromorphone • Important not to rely on parent/metabolite ratios, which change throughout metabolic cycle

Opioid Issues

Parent compound eliminated more quickly than metabolites • A person taking oxycodone could have drug test positive only for oxymorphone • Someone taking hydrocodone could have drug test positive only for hydromorphone • Important not to rely on parent/metabolite ratios, which change throughout metabolic cycle, except Both codeine and more commonly morphine may produce minor metabolites • *When a large amount of morphine is present, hydromorphone may be seen in a quantity up to 15% of the total morphine * • Large amounts of codeine are present • Hydrocodone has also been reported

Reviewing Positive Test Results

Phencyclidine, MDMA • No medical explanation • Why communicate with donor? Cocaine • ENT, ophthalmology, surgery, Emerg. Dept. Marijuana Metabolites • The only *federally-acceptable* medical explanation for THC positive is an authorized prescription for *Marinol* • Non-federal: depends on company policy and state laws • MJ use increases risk of motor vehicle crashes; *commercial drivers cannot use medical marijuana*

Opiate Result Reporting

Positive • Unable to contact donor (72 hour and 10 day rule) • Donor refuses to talk with MRO • 6 AM (heroin) and morphine present • >15,000 ng and no medical use documentation • Independent clinical evidence of unauthorized opiate use (admission of use on history or findings on clinical examination) Negative • >15,000 ng & acceptable medical use • >2,000- <15,000 ng/mL & no independent clinical evidence of illicit opiate use

Opiate Positive Verification

Positive 6 Acetyl Morphine analysis • no acceptable medical explanation for 6AM (heroin) • *Morphine/Codeine >15,000* ng/mL, *donor* must provide documented medical explanation *Morphine/Codeine (>2,000- <15,000*ng/mL) requires *independent clinical evidence* of unauthorized opiate use • Clinical evidence* obtained from medical examination/interview • Rule is silent on "spousal use" issue • Admission of illicit use of other drugs is not clinical evidence of illicit morphine/codeine use

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Propoxyphene

Propoxyphene-containing medications were removed from the U.S. market in November 2010

Hair versus Urine

Pros: • Less invasive collection - directly observed • Multiple sampling for hair - drug use history by segmentation, although latest data may challenge this • Easier shipment and storage • More resistant to adulteration and substitution Cons: • Variations in detection windows • Less is known about the science - dose vs concentration studies • More sensitive procedures needed - however, advanced MS technology more than capable today • Proficiency Testing Programs - difficult to establish for hair

Testing of Split Specimens: Validity

Re-tests for adulterants - must test for adulterant(s) confirmed in primary specimen - use same criteria for determination in re-test Re-tests for substitution - use same criteria as initial lab. Lab. performing testing on the split can send to another HHS certified lab. if necessary

MRO REFUSALS TO TEST

Refusal to Test determinations always require MRO explanatory remarks • Specimen Adulterated - Specify adulterant or adulterant criteria • Specimen Substituted - Specify substitution criteria • No specimen provided (Shy bladder) - no medical explanation • Donor admission of adulterating or substituting a specimen NOTE: These are the only refusals to test the MRO reports to the Clearinghouse on FMCSA drug tests

Correctable Flaws

Require a signed statement of correction from the individual committing the error; MRO must cancel test if flaw is not corrected • Collector's signature is omitted • No donor signature & no remark explaining failure to sign • Certifying scientist signature is missing for a non-negative result • Non-federal form used in error for a DOT-mandated test • Expired version of Federal CCF is used OR Request statement of correction; however, do not cancel test if statement is unavailable: • Specimen temperature was not checked and there was no remark

Alcohol Biomarkers: Ethanol Glucuronide (EtG) and Ethanol Sulfate (EtS)

SAMHSA Interpretation Guidelines: • 1000 ng/mL ("high" positive) - heavy drinking prior 48 hrs. - light drinking same day • 500-1000 ng/mL ("low" positive) - previous heavy drinking (1-3 days) - recent light drinking (prior 24 hours) - "intense" extraneous exposure (last 24 hours) • 100-500 ng/mL ("very low" positive) - previous heavy drinking (1-3 days) - previous light drinking (12-36 hours) - recent extraneous exposure

SAP Follow-up Testing

SAP determines the number and frequency/duration of followup tests • Minimum of 6 tests during the first 12 months after return to duty • Can last up to 60 months SAP can terminate requirement after the first year of testing Requirements follow the employee from employer to employer until all follow-up tests are completed

SAP Other Points

SAP reports • Must be sent directly to the employer (can send parallel copy to C/TPA [consortium 3rd party administrator) Return to duty is an employer's decision • Only after SAP's Follow-up evaluation shows successful compliance with recommended treatment/education • Only after a negative return-to-duty test SAP does not make "fitness for duty" determination

Medications Sold in the United States that Can Cause Confirmed Positive Drug Test Results: Opioids: -Codeine

Several states allow over-the-counter sales of codeine- containing cough medicines Cheratussin with codeine Synalgos Many drugs are sold in combination with codeine as stated in their names, e.g., Promethazine with codeine, Tylenol with codeine etc.

Hair Testing: Talking Points - External Contamination

Significant discussion on external contamination and wash procedures: • No consensus on procedure to be used -various solvents and chemicals used, enzymatic procedures also • Important to test washes to insure no drugs are detected • Some reports that surface contaminants move into the hair during the wash • Detection of drug metabolites -important to overcome claims of external contamination

Urine Specimen Collection Supplies

Specimen Collection "kit" • 2 Specimen bottles with caps/lids • Collection container • Specimen bag/pouch (clear plastic) • Temperature device (usually affixed to collection container) • Shipping container (not required if being transported to lab by courier) • Collection kit and CCF usually supplied by laboratory Federal Custody and Control Form (CCF) • Pre-printed unique specimen ID # • 5 copies of the form • Bottle seals/labels attached • Requires donor's and collector's signatures • Must include MRO & Employer information Pen, rubber gloves, bluing agent, tape

Reporting of Methamphetamine Positives

Specimens must contain -- at least 250 ng/mL of methamphetamine -- *AND* at least 100 ng/mL of amphetamine to be reported positive for methamphetamine Eg: Methamphetamine - 2000 ng/mL, amphetamine 600 ng/mL - POSITIVE METHAMPHETAMINE AND AMPHETAMINE Methamphetamine - 2000 ng/mL, amphetamine 200 ng/mL (b/c cutoff is 250?) - POSITIVE METHAMPHETAMINE Methamphetamine - 2000 ng/mL, amphetamine 75 ng/mL - NEGATIVE Amphetamine 600 ng/mL - POSITIVE AMPHETAMINE

HHS/DOT Mandatory *Confirmation* Cut-Offs (ng/mL)

THCA 15 Benzoylecgonine (cocaine) 100 Codeine 2000 Morphine 2000 Hydrocodone 100 Hydromorphone 100 Oxycodone 100 Oxymorphone 100 6-Monoacetylmorphine (Heroin) 10 Phencyclidine 25 Methamphetamine 250 Amphetamine 250 MDMA 250

MRO CANCELLED TESTS

The MRO makes a determination of Test Cancelled for the following: • Rejected for testing by the laboratory • Correctable flaws that cannot be corrected with signed statements • Medical condition explaining inability to provide a urine specimen (shy bladder) Invalid test results reported by the laboratory • Consultation with laboratory scientist required • Donor Interview required Split specimen is requested by donor and is unavailable for reconfirmation analysis • Originally reported positive/refusal to test is cancelled

MEDICATION SAFETY CONCERN & FITNESS FOR DUTY

The MRO must continue to evaluate the potential for adverse impact of medication use on safety as part of employee verification interview. If the MRO believes there is a significant safety risk with the employee's continued use of the medication(s), the MRO will instruct the employee to have his/her prescribing HCP contact the MRO to discuss possible change to or discontinuance of the medication(s). • If the prescribing HCP does not contact the MRO within 5 days, the MRO reports a safety concern to the employer • If the prescribing HCP discontinues the medication or changes the medication to one that does not present a significant safety risk, the MRO does not report a safety concern • If the prescribing HCP contacts the MRO and states that the medication is not being changed or discontinued, the MRO may report NOTE: The DOT rule (40.135e) now specifies that the MRO must report the Negative result to the employer and then wait before reporting a medication "safety-concern" until the above process is complete

2018: DOT Safety Notification Changes

Timing of safety notifications to employer During the interview: • MRO *must* notify donor of safety concerns about prescriptions • MRO *must* give donor the option to have the prescribing physician contact MRO within 5 business days to discuss alternative treatment that would alleviate concerns *MRO must send employer a negative report as soon as the RX is verified* NEW REQUIREMENT: • "5-Day Pause" - Even though the verified negative is reported, if the concern is about *medication*, MRO must allow up to 5 business days for the prescribing physician to contact the MRO to see if the medication of concern can be changed. • The donor may elect to accept this option or not. If not, the safety concern can be reported to the DER immediately. • If donor accepts this option, MRO should help donors facilitate the discussion with the prescribing physician to expedite this process • If the prescribing physician *does not* contact the MRO within 5 days after your donor interview, then the MRO must notify the employer of the safety concern. • If the prescribing physician *does* contact the MRO and changes the drug, the MRO may elect not to notify the employer of a safety concern. • If the prescribing physician contacts the MRO after the 5 day period and changes the drug, the MRO *must* contact the employer and remove the safety concern. • MROs should use "reasonable medical judgment" about the safety concern if the prescribing physician refuses to change the drug, even if the prescribing physician insists the drug is safe • MROs should collaborate with their client employers about protocols for following this new regulation • MROs are not allowed to question whether the prescribing physician should have prescribed that medication

9. Report Results

To Employer within 24 hr of completing verification of non-negatives • Immediate telephone call recommended • Follow with written report (electronic OK) • If positive, give drug name, but not quantitative result • If adulterated or substituted, report details To Donor or authorized designee To court of law, if requested To DHHS/DOT (e.g., if split failed to reconfirm or if substituted result is canceled)

Specimen Substituted

Two criteria must be met: • *Specific Gravity < 1.0010 or > 1.0200* AND *• Creatinine <2.0 mg/dL* • If only one criterion met, lab reports as Invalid • Follow substitution procedures outlined below

Relative Distribution of alcohol in Body Fluids

Urine 1.3 (0.21 - 2.65) Saliva 1.12 (0.97 - 1.40) Breast Milk 1.1 *Blood 1.0 * Plasma 1.16 (1.13 - 1.18) Brain 0.87 (0.31 - 8.00) Fat 0.02 *Breath 1/2100*

Greater then 80% l-isomer Methamphetamine

consider to be Vicks Inhaler

Validity Testing

evaluation of the specimen to determine if it is consistent with normal human urine. The purpose is to determine whether - certain* adulterants* or foreign substances were added to the urine, - if the urine was *diluted*, - or if the specimen was *substituted*. A lab must do Ur Creatine value to check for substitution - and if creatinine conc. is less than 20 mg/dL must check SG Lab must also Determine the pH on every specimen, test for oxidizing adulterants and Perform additional validity tests when the following conditions are observed: • Abnormal physical characteristics • Reactions or responses characteristic of an adulterant....... • Possible unidentified interference or adulterant

CONSEQUENCES - Employees who engage in prohibited conduct must be

immediately removed from safety-sensitive functions and referred to SAP for evaluation Such employees cannot return to work until: • Evaluated by a SAP • Compliant with recommended treatment • Negative on a return-to-duty test • A follow-up testing program is established

CONSEQUENCES: 0.02 -0.039 ALCOHOL CONCENTRATION

must be removed from safety- sensitive functions until: • 24 hours have elapsed (FMCSA Federal Motor Carrier Safety Admin. ) • Next duty shift (at least 8 hours) (FRA Federal Railroad Administration) • Re-tested and below 0.02 (FTA, FAA, PHMSA), or for at least 8 hours

EMPLOYEE STAND DOWN WAIVER

refers to the practice of removing an employee from performing DOT-covered safety-sensitive functions upon notice of a laboratory report of a positive, adulterated, or substituted DRUG test, prior to MRO verification of that result • Stand Down is prohibited unless the employer has a waiver from a DOT agency • Granted in writing by DOT Agency (Few waivers granted) • DOT Agency may impose conditions and may suspend or revoke waiver

CCF Step 6 (Copy 2-5)

—completed & signed by MRO • For laboratory negatives, can be completed and signed by MRO staff • For non-negatives must be completed and signed by MRO

DHHS Verification Guidance

• "The MRO should use reasonable medical judgment to make the decision that the provided prescription was generated in response to the donor's current medical condition." • "When determining whether a legitimate medical explanation exists for a positive test, the MRO may consider whether a medication was used during the time period for which it was legitimately prescribed." • No specific guideline about age of prescriptions

CANCELED TESTS (alcohol): Fatal Flaws—confirmation test

• <15 minutes between screen & confirmation • No air blank conducted before confirmation • Air blank result > 0.00 • EBT did not print result • Next EBT calibration check outside tolerance range

THC-V (tetrahydrocannabivarin)

• A metabolite produced only by combustion of THC, therefore not present in Marinol (dronabinol) • Used to differentiate *smoked THC from dronabinol* • Presence is consistent with THC smoking • But THC-V is not always present, so absence does not disprove that THC came from smoking • Only tested in two DHHS-certified labs

DOT Pre-Employment Drug Test Exception

• A person with a bonafide longstanding incapability for normally producing sufficient quantities of urine, may satisfy the pre-employment, return-to-duty, or follow-up testing requirement Medical condition must be documented by a physician exam • Exam findings reviewed by MRO • Applicant must be examined for "clinical signs of drug use"(blood, oral fluid, hair test allowed); exam findings reported to MRO • If all clear, MRO reports a negative test result • If evidence of drug use is found, MRO reports test as cancelled (applicant cannot be hired)

CANCELED TESTS (alcohol): Fatal Flaws—saliva screening test

• ASD not read within proper timeframe • ASD did not activate • ASD expiration date past

CCF DE MINIMUS ERRORS

• Address or phone number errors (donor/empl/MRO) • Donor SSN incorrect • Reason for Test not checked • Drug tests to be performed not checked • Collector name illegible or missing • Split not checked

Minimal (de minimus) Flaws

• Address or phone number errors (donor/employee/MRO) • Donor SSN or ID# is incorrect or omitted • Testing Authority box not checked • Reason for Test not checked • Drug tests to be performed not checked • Collector name illegible or missing • Split specimen not checked

OF Collection Sites & Supplies

• An oral fluid specimen collection device must provide: • A volume indicator that at least 1 mL of oral fluid has been collected • 1 mL neat oral fluid • If a diluent is used, the volume of oral fluid collected should be at least 1.0 mL ±10 percent, and the volume of diluent in the device should be within ±2.5 percent of the diluent target volume • A sealable, non-leaking container that maintains the integrity of the specimen during storage and transport • Components that ensure pre-analytical drug and drug metabolite stability • Components that do not substantially affect the composition of drugs and/or drug metabolites in the oral fluid specimen

•Correctable Flaws (alcohol) include:

• BAT/STT fails to sign the ATF • BAT/STT fails to note employee's refusal to sign ATF (Step 4) if confirmation result is >0.02 • Use of non-DOT ATF for a DOT test •BAT/STT can correct or repeat a test if error is discovered while employee is still at testing site Breath Alcohol Technicians (BAT) Screening Test Technicians (STT)

Screening Test Technicians (STT)

• Can conduct only screening test (breath or saliva) • Required training & proficiency demonstration • Refresher and error correction training also required • BATs can serve as STT if they are proficient in use of ASD

DOT urine Collection Prohibitions

• Cannot require donor to sign "consent or release" form • Cannot conduct collection on unconscious donor Cannot collect urine by catheterization • If donor normally voids via self-catheterization, he/she must provide specimen • Special provisions for collecting from Foley catheter for post-accident test when employee is hospitalized

Recordkeeping

• Client policies, procedures, protocols • Receipt of CCFs (fax, electronic) • MRO docs (checklists and tracking forms) • Completed cases (5 yr non-negative/1 yr neg.) • Log of all "problem cases" (e.g., statements of correction to CCF) • List of negatives (5%) audited by MRO • Records of training, certification, continuing education

CCF Step 4

• Collector printed name & signature; date & time of collection • Completed after donor has completed Step 5 on Copy 2 of CCF • Collector identifies shipping service for sending specimens to laboratory (e.g. FedEx, UPS, laboratory courier)

CCF CORRECTIBLE ERRORS

• Collector signature omitted • No donor signature or remark explaining failure to sign • Certifying scientist signature missing for non-negative • Non-DOT or outdated form used for DOT test • Temperature box not checked

OF Collection Procedures

• Collector tells donor to open mouth and remove any items that may interfere with collection of oral fluid (gum, candy, food, tobacco, etc.) • Collector visually inspects oral cavity • Provide up to 4 oz of water for donor to rinse mouth • If donor claims "dry mouth," 4 oz of water may be provided to rinse or drink • Collector observes donor during *10-minute wait period* before collecting specimen • Collector explains collection procedures and completes Step 1 of CCF • Donor is provided sealed/wrapped collection device, which is opened in donor's presence • Donor positions collection device between gum and cheek in the mouth; collector observes • When volume indicator demonstrates collection of sufficient specimen, donor removes collection device from mouth and places it in the specimen vial or tube • Split specimen collection is required, either using two separate collection devices simultaneously (one in each side of the mouth), or using a second collection device immediately following the completion of the first specimen collection • In the presence of the donor, the collector places a tamper-evident label/seal from the Federal CCF over the cap of each specimen tube. The collector records the date of the collection on the tamper-evident labels/seals. • Donor initials the labels/seals on each specimen tube • Collector completes information on CCF • Donor reads certification statement on CCF, signs & dates CCF • Collector signs and prints their name on the Federal CCF • Collector seals the specimens (Tube A & Tube B) in a package and, within 24 hours or during the next business day, sends them to the HHS-certified laboratory

Current HHS/DOT Status of Hair Testing

• Consensus studies - early 2000s • Congress authorized use of HT for preemployment testing in trucking industry and required HHS to develop regulations and guidelines by Dec.16, 2015 • DTAB recommendation made to SAMHSA August 2015 to proceed with development of MG for Hair Testing in Federal Workplace Drug Testing Programs • Draft Hair Testing MG were written and submitted to OMB for approval and release in 2019; no proposed MG to date • No DOT action on hair testing until HHS issues HT MG

12. Assess Safety Risks & FFD (fitness for duty)

• Consider job duties - know your employer • Review medications - potential adverse effects • Assess safety risks - safety sensitive functions • Report concerns - DOT provisions - Fitness for duty issues - report immediately - Medication concerns - *allow 5 days for treating physician to change prescription*

For DOT tests the MRO must not:

• Consider results of other tests (oral fluid, blood, hair, DNA) • Accept procedural irregularities not evidenced on CCF • Decide whether donor should have been tested • Accept non-medical explanations for test result • Accept explanations of "medical use" that are not documented by a physician's lawful prescription or administration of a drug • Accept hemp, coca or CBD products ingestion claims • Accept any explanation for PCP, Heroin or MDMA as legitimate • Accept soap, bleach or gluteraldehyde physiologically occurring in urine • Accept a medical explanation for no creatinine in a urine specimen

Hair: Pharmacology

• Consists of a follicle (bulb) and shaft • Grows in three stages: • Anagen - active growth, normally about 85% of scalp hair follicles in this phase (lower percent for other body hair) • Catagen - transition phase • Telogen - resting phase • Vertex region of scalp - grows at 0.4 mm per day (or *1 cm per month*) • Many protocols specify collection of 1.5 inches (approximately 90 days) Incorporated by several different pathways: • Passive diffusion into the follicle base • Embedded into hair as bands during growth - amount of drug deposited proportional to blood concentration and the distance of band from surface can estimate time of use • Via secretions of the apocrine sweat glands and the sebaceous glands - adsorbed into the shaft during and after its formation

Distribution of the CCF

• Copy 1 to the laboratory with the specimens (in the plastic bag) • Copy 2 to the MRO (fax or electronically transmit to MRO; send within 24 hrs.) • Copy 3 Collector retains for 30 days • Copy 4 to Employer DER (fax/email to DER; send within 24 hrs.) • Copy 5 give to donor after CCF is complete & bottles are packaged

EAP (Employee Assistance Programs) and DOT Rules

• DOT rules include EAPs in the context of providing supervisor and employee training and drug/alcohol awareness information • Employer may provide SAP services thru EAP if EAP has qualified SAP staff • EAP may serve as referral agent to SAP for DOT-covered employees • EAP cannot return a DOT-covered employee to work without SAP return to duty process

Interpretation of Alcohol Results

• Direct link between breath (blood) alcohol and impairment •Impairments observed at blood alcohol concentrations as low as 0.02% weight/volume (w/v) • After peaking, blood concentration decreases at an average rate of 0.018% per hour. The range is 0.005 to 0.03% per hour.

4. Record Pertinent Findings

• Document MRO reviews • What occurred; how decision was made Use MRO Punchlist / Checklist / Contact Record • Documents valid, consistent, standard operating procedure • Log each attempt at contact • Document timing for 3 day, 10 day clocks • Validate meds. with physician/pharmacist

MRO Verification without Donor Interview

• Donor expressly refuses to talk to MRO • Donor failed to contact MRO within 72 hours after notification by the DER ("3-Day Rule") • No MRO or DER contact with donor after 10 days ("10-Day Rule") • MRO may "re-open" verification process if donor presents "exceptional circumstances" within 60 days • All donor contact attempts must be documented

"Dry Mouth" Procedures for oral fluid collections

• Donor must make an attempt to provide a specimen • The donor demonstrates their inability to provide a specimen when, after 15 minutes of using the collection device, there is insufficient volume or no oral fluid collected using the device • If the donor states that they could provide a specimen after drinking some fluids, the collector gives the donor a drink (up to 8 ounces) and waits an additional 10 minutes before beginning the specimen collection • A period of 1 hour must be provided or until the donor has provided a sufficient oral fluid specimen • If federal agency has authorized it, a urine specimen may be collected when a donor cannot produce an oral fluid specimen • If no authorization for a urine specimen collection, the same procedures used for "shy bladder" are followed (i.e., medical examination with final determination made by MRO)

Employee Assistance Programs Functions

• Educating employees about alcohol and drugs • Exploring personal problems affecting work performance • Training supervisors to recognize signs and symptoms of substance abuse & to act as referral agents to the EAP • Consulting on specific cases • Referring employees for assistance/treatment • Evaluating employees for return to work

USCG (46 CFR Parts 4 & 16) U.S. Coast Guard

• Employee training is required • MRO makes determination of employee's "risk of drug use" in return to work letter • Mariner certificate actions taken by USCG • Periodic drug test required at time of license renewal; USCG form must be signed by MRO No alcohol testing required except for post-accident • PA Alcohol testing does not have to follow Part 40 procedures

FAA (14 CFR Part 120) (Aviation)

• Employers must certify their compliance to the FAA • Pilot medical certificate actions • MRO determination to FAS for pilot violations • Recurrent supervisory training • Permanent Bar provisions • Cannot work in FAA covered position after 2nd drug/alcohol violation or after 1st incident of on-duty drug use • Requirement to transfer MRO records if employer changes MRO

RANDOM DRUG TESTING

• Employers must conduct random tests of a minimum annual percentage of safety-sensitive employees Random tests must be spread reasonably throughout the year • Random selections must be made at least quarterly Each DOT agency determines annual percentage based on random positive rate from previous year(s). • Positives <1%, random rate 25%; ≥1%, random rate 50% • For 2020: FAA, FRA-Hours of Service workers 25% FMCSA, FTA, PHMSA, USCG, FRA-Maintenance of Way workers, 50%

7. Refer for Medical Evaluation

• Evaluation of Shy Bladder, Shy Lung, Shy Mouth • Examination for clinical signs of opiate abuse • Condition that might explain a Substituted or Adulterated specimen • MRO can perform these evaluations, but must function in a different role (clinician)

DOT - Dept. of Transportation

• FAA - Federal Aviation Administration • FHWA - Federal Highway Administration • FMCSA - Federal Motor Carrier Safety Admin. • FRA - Federal Railroad Administration • PHMSA: Pipeline Hazardous Material Safety Admin. • FTA - Federal Transit Administration (mass transit) • USCG - U.S. Coast Guard • NTSB - Natl. Transportation Safety Board

SAP Responsibilities

• Face-to-face clinical assessment and evaluation • Refer to appropriate program • Face-to-face follow-up evaluation • Recommendations for employee continuing education and/or treatment • Follow-up testing plan • Report directly to employer Initial Evaluation • Must recommend assistance/treatment in every case • Recommend the most appropriate course of education and/or treatment • Must *not* consider claims of: inappropriate selection; hemp oil or medical MJ; poppy seed use; job stress excuses • May consult with MRO and may request quantitative levels on test result Appropriate education: • Self-help groups (e.g., 12-step, AA) • Community lectures • Drug and alcohol awareness education courses Appropriate treatment: • In-patient hospitalization • Partial in-patient treatment • Out-patient counseling programs • Aftercare • Employer or employee cannot seek additional evaluation(s) • Employer or employee cannot change a SAP's evaluation • SAP may modify recommendations based on additional information from treatment provider • SAP responsible for making referral to appropriate treatment/education provider

The Employer of a Discharged Positive Employee Has No Obligation To:

• Facilitate a referral to a SAP, but must provide SAP contact information • Ensure that the employee undergoes a SAP evaluation • Pay for the employee's SAP evaluation • Pay for or facilitate the SAP-recommended treatment • Reinstate a rehabilitated employee • Maintain the SAP evaluation records

HHS Mandatory Guidelines for Oral Fluid Drug Testing (OFMG)--Impact

• Federal agencies may use OF testing for all the same testing reasons as currently authorized for urine drug testing. • A federal agency may use urine and/or oral fluid drug testing in accordance with its HHS approved Drug Free Workplace Plan. • The OFMG contain provisions for OF specimen to be used when an individual cannot provide an adequate volume urine specimen, and for a urine specimen to be used when an individual cannot produce an adequate volume OF specimen. • In order for OF testing to be used in Department of Transportation (DOT) or Nuclear Regulatory Commission (NRC) mandated testing, those agencies will need to engage in separate rulemaking activities. • OF MG will have an impact on non-federal DFWP testing programs, especially in those states where State laws and regulations reference the HHS MG as the standard for workplace drug testing procedures and requirements

Positive Test Verification

• For all positives the donor must present acceptable documentation of an "alternative medical explanation" for the drug(s). • The one exception is opiates <15,000ng/mL • MRO may allow up to 5 days to provide documentation of medical use • If there is a legitimate medical explanation, the test is reported as Negative • MRO must also assess Workplace Safety concerns (2ndhat)

PRIOR TEST RESULTS CHECK

• For candidates for safety-sensitive positions employer must check previous employers for DOT Drug & Alcohol rule violations • Must also ask candidates if they tested positive or refused to test on any DOT pre-employment tests • Candidates must sign release of information form Check must go back *2 years* (from date of application), except for CDL positions which require check of past 3 years for D/A violations • FMCSA employers must conduct pre-employment query of FMCSA Clearinghouse on every driver applicant beginning Jan 2020 • FMCSA employers must continue to do prior employer check till 2023 • If violations are reported, employer must obtain SAP, Return to duty & follow-up test information • Must have info within 30 days of employee performing safety-sensitive functions, or have made good faith effort to comply • Must request & receive info in writing • Must provide candidate's signed release to previous employers

Alcohol Absorption

• Generally all absorbed within 30 to 60 minutes • Absorption slowed by food, increased by carbonated drinks, e.g., champagne, beer • Gastric alcohol dehydrogenase (GAD) metabolizes • Women: 50% less GAD than men, leads to increased absorption • Male alcoholics: 50% more GAD, leads to decreased absorption compared to non-alcoholic men

Confidentiality - HIPAA

• HHS and DOT have both stated that *employers and services agents are not required to obtain employee written authorization in order to disclose drug and alcohol testing information* • MROs need no employee authorization to verify drug test results, discuss alternative medical explanations with prescribing physicians and issuing pharmacists, to confer with SAPs, or to report results • Nonetheless, most treating physician offices seek HIPAA waiver before disclosure

DOT Changes - January 1, 2018

• Harmonized to DHHS October 1, 2017 Update • MRO must report safety concerns • If concern is about Rx meds, MRO must before notifying DER allow 5-day "pause" for treating HCP to change medications Expanded list of Fatal Flaws • DNA not allowed for drug testing

Opiates/Opioids Routes of Administration

• Heroin, morphine, Dilaudid, fentanyl, sufentanil, and meperidine are usually injected • Codeine, oxycodone, hydrocodone, MS Contin, pentazocine, and methadone are usually taken orally • Opium is usually smoked. Heroin and morphine may be smoked or insufflated nasally • Fentanyl may also be administered by patch.

Positive Test Verification - Issues for MRO Discretion

• If drug was obtained legally in a foreign country, the MRO may determine if there was a legitimate medical reason for the use of the drug and if it was used consistently with its intended medical purpose (Schedule 1 drug excepted) • Use of family or friend's medication - "spousal use" • Use of "old" medicines, e.g., prescribed >6 months ago • Internet drug prescriptions - 2009: Ryan Haight Act made it illegal to dispense controlled substances via internet

Repeated Invalid Specimens

• If first specimen was *invalid without medical explanation*, second specimen collected under direct observation. • If properly collected second specimen is also verified as *invalid for same reasons* without medical explanation, collection of a third specimen is not authorized. • If second specimen was *invalid for a different reason*, a third specimen must be collected under direct observation. • If properly collected third specimen is also verified as *invalid for same reasons*, further collection is not authorized.

EMPLOYER ACTIONS • For verified positive, adulterated or substituted results:

• Immediate removal from safety-sensitive duties • Cannot defer removal until written test result is received or split result is known • Contact information for Substance Abuse Professional (SAP)—a list of local SAPs, including names and telephone numbers

Hair Collection Issues

• In absence of adequate head hair, other body hair may be difficult to obtain in adequate quantity and privacy • Difficulty with detecting wigs, hair pieces and hair weaves • Difficulty with determining adequate specimen for very close cropped or curly hair; requires weighing specimen • Difficulty in handling and placing hair while wearing gloves • Closely braided or plaited hair should be unbraided before cutting sample

Criteria for invalid sample

• Inconsistent creatinine conc. and specific gravity results are obtained, i.e., (creatinine conc. is less than 2 mg/dL and specific gravity is greater than 1.0010 but less than 1.0200) OR (specific gravity is less than or equal to 1.0010 and creatinine conc. is greater than or equal to 2 mg/dL) • pH is greater than or equal to 4 and less than 4.5 or greater than or equal to 9 and less than 11 • The nitrite (or nitrite equivalent) conc. is greater than or equal to 200 mcg/mL but less than 500 mcg/mL [Note: max with UTI is 125] The *possible presence* is determined of • chromium (VI) • a halogen • glutaraldehyde • an oxidizing adulterant • a surfactant • Interference occurs with the immunoassay drug tests • Interference occurs with the GC/MS drug confirmation tests • The physical appearance of the specimen is such that it may damage the lab's instruments

Differences in MRO Role in non-DOT Testing

• Interpretation of expanded drug panel • Interpretation of results from other specimens • Interpretive issues related to medical marijuana, foreign medications, spousal use, etc. • MRO may serve as SAP or examining physician • Fitness for Duty and Return to Work determinations • Interpretation of alcohol test results • Development and monitoring of "post-rehab" testing program

HHS Guidance to MROs on Marijuana, Hemp, CBD

• July 24, 2019 SAMHSA's Division of Workplace Programs (DWP) issued a memorandum to MROs about the impact of marijuana and hemp products use on federal drug tests reported positive for THCA • 2018 Farm Bill removed hemp from the definition of marijuana within the Controlled Substances Act (CSA). • The THC level in hemp-derived products must be *no greater than 0.3 percent on a dry weight basis in order to satisfy the revised definition of "hemp" provided in the Farm Bill. *If hemp-derived products exceed that THC threshold, they do not meet the definition of hemp, and are classified as Schedule I. The FDA does not certify levels of THC in hemp or CBD products. • Many CBD products' labeling does not accurately reflect their content. The amount of CBD in the majority of tested CBD products was inconsistent with that on the label, with most containing more than 0.3% THC, up to 6.4 mg/mL. • An employee's drug test may be positive for the THC metabolite due to THC in the CBD product. •* Under the federal DFWP, there is no legitimate medical explanation for a marijuana positive test result other than a verified prescription for Marinol®, Sativex® or generic equivalent. * • "In summary, the passage of the 2018 Farm Bill legalized hempderived products under certain conditions, but it does not change the policy on marijuana use under the DFWP. Therefore, federal agencies should make every effort to inform applicants and employees of the risk that using such products may result in a positive marijuana test.

POSITIVE RESULTS

• MRO Remarks: Drug(s) detected must be specified • No quantitative levels provided • If Dilute, enter in Remarks section • Dilute actions regarding recollection do not apply

Broad MRO Role in DOT Testing

• MRO is "gatekeeper" of testing process • Responsible for reviewing custody and control form for errors (negatives and positives) • Must notify collector or employer when error causes cancellation of test result • Must offer to interview donor with Positive, Adulterated, Substituted and Invalid test results • Must review "shy bladder" medical findings • Under DOT, must report medical information to employer when safety or medical qualification is an issue

MRO Results Reporting

• MRO must review CCF Copy 2 (or equivalent copy) before reporting any DOT test result • Negative results may be transmitted electronically (employer must be able to produce "paper copy") • Non-negative results must have MRO's signature (must be reported same or next business day) • The MRO can transmit verified results to a TPA if the employer so directs • MRO can use CCF or other form with same test results for reporting to Employer/TPA

Split Specimen for Adulterated/ Substituted

• MRO offers opportunity for split specimen analysis just as with a confirmed positive test • Employer policy determines who pays • Laboratory must analyze split using original substitution or adulterant criteria

Donor Contact Process

• MRO staff must document 3 attempts spaced over 24 hours to contact donor • After attempts, request DER (Designated Employer Representative) to contact donor DER must document 3 attempts in 24 hours *• If successful, DER tells donor to contact MRO within 72 hours* (starts 3-day clock) *• If unsuccessful, DER must notify MRO* MRO staff may contact donor, but no part of donor interview may be conducted by staff

MRO Responsibilities for Adulterated & Substituted Specimens

• MRO treats substituted/adulterated specimens in the same way as a confirmed positive test • Donor interview required • Must explain to donor laboratory findings and address technical questions or issues • Split sample offer must be made to donor • Must offer the donor the opportunity to present "a legitimate medical explanation" for the lab findings Donor has "burden of proof" to prove: • Adulterant occurs naturally in their urine, or • Low specific gravity & creatinine are physiologically possible for their specimen • MRO must exercise "best professional judgment" to determine if employee has established a legitimate medical explanation • If explanation is *not* acceptable to MRO, report laboratory finding to employer and "Refusal to Test" • If MRO determines donor's explanation *may* provide a "reasonable basis" for a legitimate explanation, additional steps must be followed (see Part 40.145) • Neither MRO nor employer responsible for costs associated with obtaining this information • If MRO determines acceptable explanation exists, test is "Cancelled" and written report is made to ODAPC • Otherwise, report laboratory findings and "Refusal to Test"

Liabilities and Legal Issues

• MRO's duty is to employer • MRO acts as a service agent • MRO must comply with applicable federal and state law • HHS, DOT, ADA • See Limiting Risk by William J. Judge, JD

Concerns About DOT 5-Day Wait

• MROs may be less inclined to flag and report safety concerns • Potential for MRO to forget to report after 5 days • Challenge to employer of hiring an applicant or returning an employee to work with a negative, later to receive a safety warning • Liability for accidents occurring when MRO knows of but has not reported safety concern

Reporting to FMCSA Clearinghouse (Federal Motor Carrier Safety Admin.)

• MROs must register online • Invite MRO Assistants - to allow access • Report positives, adulterated, substituted, shy bladder (refusals-to-test) within 2 business days • Report changes within 1 business day • May need to contact employer to get needed info, e.g., driver name, CDL#, DOB, state

Morphine and Codeine

• Major metabolite of heroin • Also metabolite of codeine - "normal" metabolizers approximately 3:1 ration for codeine and morphine • Constituents of opium - morphine generally higher concentrations • Therapeutic uses of morphine and codeine: many

2. Review Results

• Make sure they represent a valid test • Examine Custody and Control Form (CCF) • "Administrative Review" of negatives • MRO review of "non-negatives (positives, adulterated, substituted, and invalid specimens) • Lab may identify a flaw; MRO must decide its significance

HHS Mandated *Screening* Cut-Offs (ng/ml)

• Marijuana Metabolites (THCA) 50 • Cocaine Metabolites 150 • Codeine/Morphine 2000 • Hydrocodone/Hydromorphone 300 • Oxycodone/Oxymorphone 100 • 6-Acetylmorphine (Heroin) 10 • Phencyclidine 25 • Amphetamines/Methamphetamine 500 • MDMA/MDA 500

Amphetamine Issues

• Metabolites of other preparations e.g, benzphetamine, pchlorobenzphetamine (from Mexico), Selegeline (as the l-isomers). • Immunoassays detect other sympathomimetics e.g. ephedrine, pseudoephedrine and phenylpropanolamine, often at only very high concentrations. Can be differentiated by GC/MS • "Bath Salts" - Cathinone derivatives with effects similar to cocaine, amphetamine or MDMA

Poppy Seeds

• Morphine is present, amount depends on geographical origin • Urine morphine concentration can be in the thousands of ng/mL, usually in the hundreds • Codeine usually very low, often cannot be detected

Oral Fluid Specimen Collectors

• Must be trained to collect oral fluid specimens in accordance with OF MG & the manufacturer's procedures for the collection device • Training requirements mirror urine specimen collector, including 5 error-free mock OF collections • Refresher training every 5 years • No requirement for error correction training • Immediate supervisor or hiring official may only collect a donor's specimen when no other collector is available (must meet qualification training requirements) -- Always under direct observation?

Rehabilitation & Therapeutic Medications

• Naltrexone (ReViaTM) can be used as an anti-craving agent for alcoholics • Naltrexone can be used as an opioid blocker for those at risk for using opioids • AntabuseTM (disulfiram) long used as an aversive for those at risk for using alcohol • Methadone, Buprenorphine and Suboxone (buprenorphine and naloxone) can be used for opioid maintenance for those unable to remain opioid free

MRO DETERMINATIONS ON DOT RESULTS

• Negative Negative-dilute • Positive (with name of drug(s)) Positive-dilute • Refusal to Test* *Require remarks for explanation of result • Test Cancelled

11. Recordkeep

• Negatives - 1 year • Positives and Non-Negatives - 5 years • Drug test results should be separated from patient medical chart because of confidentiality concerns

Non-Regulated Testing: Differences

• No Split Specimen • Panel of Drugs Tested • Specimens Tested (oral fluid, hair) • Witnessed Collection • CCF: Info re Recent Rx Medication • Cutoff Levels • On-Site (Point of Collection) Testing - Positives Kept Off Duty

MRO Reporting of Split Results

• No delay in reporting verified result pending split analysis • *Reconfirmed: *Report to DER & donor that final result is Positive(or if adulterated/substituted, Refusal to Test) *Failed to Reconfirm*- • *Drug not detected or Adulteration/Substitution criteria not met * - report to DER & donor that both test results are canceled • *Specimen not available * - Report to DER & donor that both tests are canceled & reason - Direct DER to get an immediate re-collection of specimen (direct observation) • All Failures to Reconfirm must be reported by the MRO to the DOT (ODAPC) using format in Part 40, Appendix D

DOT urine Specimen Collection Privacy Issues

• No undressing or gowning • Removal of coats, hats, jackets, etc. required • Pocket searches required • No medication inquiries • Private enclosure for urination • Donor may retain wallet (which may be inspected); must leave other hand-carried items outside toilet area Security Issues: • Wrapped collection container • Wrapped specimen bottles (donor does not take specimen bottles into toilet enclosure) • Specimen always in donor's sight • Donor signature and initials obtained after seals are placed on specimen bottles • Specimen bottles & CCF secured in plastic transport bag

HHS Mandatory Guidelines for Oral Fluid Drug Testing (OFMG) —Specimen Collection

• OF specimen collection essentially mirrors existing procedures and processes for urine drug testing. • OF specimen collections will be observed; will use an FDA-cleared specimen collection device that has a volume indicator to facilitate obtaining the 1 mL minimum volume. • Split specimens are required using 2 separate devices, collected simultaneously or serially at one specimen collection event, or using one collection device in which the specimen can be subdivided. • There is a 10-minute wait period before the specimen is collected • An OMB approved federal custody and control form (CCF) will be used to document the OF collection and establish chain of custody of the specimen. • HHS is developing a combined urine & oral fluid federal CCF that can be used for either a urine or OF test. • OF specimens will be sent to a laboratory approved by HHs for oral fluid drug testing for analysis

HHS Mandatory Guidelines for Oral Fluid Drug Testing (OFMG)--MRO

• OF test results will be reported to a qualified MRO for interpretation and final reporting to the Federal agency. • MRO requirements and procedures parallel those in place for federal urine drug testing programs. • MROs will have to complete some training on the OFMG prior to serving as an MRO for a federal agency using oral fluid drug testing.

DOT Direct Observation Procedures

• Observation by same gender individual • Direct observation must be noted in Step 2 & explained in remarks section • Donor must be told reason for direct observation • Limited to 6 special circumstances • Observer does not have to be a "trained collector" • Observer instructs donor to position clothing so that observer can view the donor's body (front and back) from the chest to the mid-thighs to inspect for a specimen substitution/adulteration device

Multiple Results on Single Specimen

• Once a specimen has been verified by MRO, multiple verified nonnegative results should be reported immediately • If donor requests analysis of split specimen, MRO should *report result to DER without waiting for split report* • If split reverses initial report, MRO can change results that were reported previously

FTA (49 CFR Part 655) Federal Transit Administration (mass transit)

• One-hour employee training • Employer certification of compliance required • Permits police administered post-accident tests in lieu of employer conducted tests • Drivers and mechanics of small vans and other vehicles used in providing public transit services are covered positions • Recipients of federal transit $$ must certify their compliance with the FTA

Amphetamines

• Only ones that can currently be reported: methamphetamine, amphetamine, and MDMA • *Amphetamine is metabolite of methamphetamine * • Excretion is pH dependent; an acidic urine enhances excretion • Methamphetamine routes of administration: injection, snorting, smoking ("ice") and oral • Amphetamine and methamphetamine still used therapeutically • No therapeutic use for MDMA

Reconfirmation

• Performed at a second certified lab • Re-test by confirmation (reconfirmation) procedure *without regard to cut-off * - determines the absence or presence of the drug or drug metabolite • To reconfirm *methamphetamine, must detect the presence of amphetamine*

Comparing Hair & Urine Testing

• Positive prevalence rates for "paired" hair and urine specimens • "Concordance" between hair and urine test results - same donor; same collection date • Positive rates higher in hair than urine for most drugs • Both specimens detect some positives that the other does not

FMCSA (49 CFR Part 382) Federal Motor Carrier Safety Admin.

• Post-accident tests by police can be used in lieu of employer conducted tests • Owner Operators must have consortium or TPA for program implementation • No periodic drug test conducted as part of DOT Driver physical examination (biennial) FMCSA National Clearinghouse rule effective Jan 2020 • MROs must report FMCSA drug tests verified as positive, adulterated or substituted and MRO determined refusal to tests (shy bladder, admission of adulteration/substitution) • Reporting must be by driver CDL#, (not SSN) & include driver name & DOB Some states still require MRO or employer to report positive or refusal to test results to State DMV • Currently, MRO must report in AR, OR, TX, WA

DOT Shy Bladder Procedures used when a donor presents no specimen or specimen volume less than 45 mL after attempting to urinate

• Provide up to 40 ounces of fluids at collection site • Provide up to 3 hours • Record attempts, time & QNS on CCF in remarks section • Never combine partial specimens • Discontinue collection after 3 hrs.; check "none provided" • Report to employer as shy bladder • Collector signs Step 4, but "lines through" certification statement • Complete Steps 1 & 2 of CCF, print donor name in Step 5 and distribute CCF copies (destroy copy 1)

PUBLIC INTEREST EXCLUSION (PIE)

• Purpose-- Protect public interest from serious noncompliance with DOT rules by service agents (e.g. collection sites, MROs, TPAs) • Initiated & investigated by DOT agency; Issued by ODAPC if Notice of Proposed Exclusion (NOPE) is not remedied • Service agent presents defense to ODAPC Director PIE NOTICE • Written notice of ODAPC decision and basis for PIE • Name of service agent listed on DOT web site and in Federal Register • Service agents must notify all DOT-regulated clients about the PIE & employers must stop using service agent's services within 90 days of issuance of PIE • PIE issued for 1-5 years, however ODAPC can adjust duration based on service agent remediation

1. Receive Results

• Receive confirmed results from lab • Not by telephone • Results electronically or by secured fax Custody and Control Form (CCF) received by fax/mail from • Collection Site (with donor's name and contact info.) • Laboratory (may omit mailing CCF for negatives)

HHS Oral Fluid Mandatory Guidelines

• Released 10/2019 effective 1/2020; will require 12-18 months to implement (labs, DOT, etc.) • Closely parallel urine collection, analysis and MRO review, with lower cutoff levels Some key differences: • THC: OF tests for THC, not THC-acid • Cocaine: OF tests for parent cocaine and benzoylecgonine • MROs must complete OFMG training for work with federal agencies

Methamphetamine Interpretation

• Remember d and l isomers of methamphetamine are the key (d and l amphetamine not at issue) • 100 ng/mL or more of amphetamine must be present for a laboratory to report a methamphetamine positive result • < 250 ng/mL amphetamine won't be reported • Know your laboratory - isomers by request? Donor Interview Should Include: • Use of medication that contains d-methamphetamine • Recent use of nasal inhaler (e.g. Vicks inhaler™) • Use of Rx drugs (e.g., selegilene) • Obtain d and l isomer characterization when history suggests use of Vicks or use of Rx meds that metabolize to l-methamphetamine

Prescription Verification

• Remember the ease of RX forgery with current electronic devices • Consider "double verification" • Ask for pharmacy record, bottle labels, doctor notes • Document what you receive

Shy Bladder Evaluation

• Required after failure to produce an adequate sample (45mL) in three hours after up to 40 ounces • MRO or other physician may perform evaluation • MRO receives & reviews information, reports decision to employer • Examination must develop pertinent data that might explain the donor's inability to produce a sample "medical condition" includes an ascertainable physiological condition (e.g., a urinary system dysfunction) or a medically documented pre-existing psychological disorder, but does not include unsupported assertions of "situational anxiety" or dehydration. Evaluation May Consist of: • Medical history (renal or GU Diagnosis, output problems) • Medication History (Anticholinergics, Hytrin) • General Physical (skin turgor, orthostatic changes) • Simple Lab tests (U/A, BUN, Creatinine) • Drug test not actually authorized • Cystoscopy, IVP usually not needed • Written report required

SPLIT SPECIMENS

• Required for all DOT and DHHS tests • Split specimens must be retained by laboratory for *1 year on all non-negative results* If the primary specimen is negative, the lab may dispose of the split sample. • Re-confirmation for drugs is based on Limit of Detection, not confirmation cut-off levels • Re-confirmation for adulterants or substitution must meet the criteria required for original confirmation • Payment for split analysis is employer responsibility, but may get reimbursement from donor

Breath Alcohol Technicians (BAT)

• Required training (DOT model curriculum) • Proficiency demonstration on EBT device • Refresher training every 5 years • Error correction training within 30 d • Supervisors should not be BATs

DOT Covered Employees: Rule Requirements

• Requires MROs to treat laboratory reported negative-dilute results with creatinine levels *greater than or equal to 2 mg/dL, but equal to or less than 5 mg/dL*, as negative-dilutes that require immediate recollection *under direct observation* • Requires laboratories to provide creatinine and specific gravity numerical for all specimens they report to the MRO as negative-dilute and positive-dilute

Issues to Clarify with Employers

• Review company policies, including drugs tested, procedures, medical and recreational marijuana, opiate use, and fitness for duty evaluations • How will they handle MRO report of "safety concerns" • How dilutes will be handled regarding retesting • Payment of split specimens, d/l separation, etc. • Use of spousal Rx medication, foreign drugs, etc. • SAP evaluation availability (list) and payment • Treatment policies, available services, payment • Collection site actions if donor is intoxicated, e.g., EBT for alcohol >0.02

Reviewing Laboratory Negative Results

• Review laboratory result (electronic or CCF) • Review CCF (MRO Copy 2) for correctable flaws • Check negative on CCF Copy 2 • MRO staff can conduct review & use signature stamp with initials • MRO must personally review & sign 5% of negatives, (up to 500/qtr) including ALL CCF's with correctible flaws

Oral Fluid Laboratory Testing Important Points to Be Made:

• Same approach as urine testing - immunoassay initial test followed by confirmation using mass spectrometric procedures • Latter may include LCMS, GCMS, LCMSMS, UltraHPLCMSMS, TOFSIMS, etc. • Chain of Custody and QC protocols similar to urine testing • *No specimen validity testing required * • THC included and *not THC metabolite * • To be certified for oral fluid testing, labs. must demonstrate competency through satisfactory performance testing and inspection

Hair Testing: Talking Points

• Same approach as urine testing - immunoassay initial test followed by confirmation using mass spectrometric procedures • Latter will include LCMS, GCMS, LCMSMS, UltraHPLCMSMS, TOFSIMS, etc. • Chain of Custody and QC protocols similar to urine testing • PT programs difficult to develop • Lab. Certification Program available through CAP • Adsorption from deposition by sweat etc. and absorption from blood/serum, sebaceous fluid • Segmentation (ability to approximate time of us by dividing strand into segments) called into question because of diffusion along the shaft as hair grows • Detailed dose to concentration studies not available -how much must the user use? • Not suitable for reasonable cause or post-accident testing because of time lag between drug use and incorporation into hair shaft

HHS Mandatory Guidelines for Oral Fluid Drug Testing (OFMG)--Laboratory

• Same drug testing panel as the HHS panel for urine drug testing, using screening and confirmatory methods. • Cut-off levels specific to OF • The target analyte for marijuana testing is THC, rather than THC-A as in urine testing. Additionally, OF testing will have both cocaine and benzoylecgonine as target analytes. • Laboratories must be approved/accredited by the HHS National Laboratory Certification Program (NLCP) for OF drug testing. • Laboratory inspection, quality assurance, and proficiency testing programs will mirror those in place for urine drug testing laboratories. • Specimen validity testing authorized, but NOT required as part of the testing process.

Preparation of DOT Urine Collection Site

• Secure water sources • Put bluing in toilet • Remove potential adulterants • Restrict access and exit • Have suitable area for completing CCF

Urine Collection Personnel

• Should not be direct supervisor of donor unless no one else is available Must complete qualification training • Training course (classroom, distance learning, Web, etc.) • Initial Proficiency Demonstration (5 consecutive error-free "mock" collections—must be monitored in person by qualified collector) Must complete *refresher training every 5 years* • Same requirements as qualification training Must undergo "error correction" training within 30 days of notification of error causing cancelled test • Review of procedures and three "mock" collections related to error committed • Must subscribe to ODAPC list-serve to receive updates from DOT

6. Reanalyze vs. Retest / Recollect

• Single vs. Split specimens • Reanalysis vs. Retesting • Only MRO can ask lab to reanalyze • MRO can request further analysis of specimen at another lab (e.g., invalid specimen) • Split specimen ("bottle B") analyzed only at Donor's request *(within 72 hours)* at another laboratory

Flaws: Fatal and Correctable

• Some CCF errors can be corrected retroactively • Omissions - yes • Discrepancies - no No set method for correcting CCF • MRO can ignore minor error or correct with initials • Written "statement of correction" for major errors • Notarized affidavit looks better in court

FRA (49 CFR-Part 219) Federal Railroad Administration

• Special post-accident testing program (includes blood, additional drugs, different cutoffs, FRA contract laboratory) • Railroad "for cause" testing (unexplained human error; operating practices violations—no individual reasonable suspicion) • Engineer certificate actions • Three-hour drug & alcohol supervisory training

Permanent "Shy Bladder" Medical Condition

• Special provisions apply only to pre-employment, and return to duty tests • MRO must determine if the individual uses illegal drugs • Requires a clinical medical examination to assess illegal drug use *(may use alternatives - oral fluid, hair, blood)* MRO reviews exam findings • If no evidence of illegal drugs—negative result • If evidence of drug use—canceled test

Alcohol Effects Correlate to BAC 0.08-0.15 BAC

• Speech slurred • Balance & coordination impaired • Reflexes slowed • Visual attention impaired • Unstable emotions • Nausea & vomiting

Substance abuse Key Take Aways

• Substances are widely used in the U.S. Most used are alcohol, tobacco, marijuana, prescription pain killers, cocaine & hallucinogens • Many factors influence unauthorized drug use, especially age, gender, geography, education, occupation and work status • Recreational use of marijuana use dramatically rose with legalization • Opioid overdoses and deaths at epidemic proportions, especially among synthetic opioids, e.g., fentanyl • Drug use begins at early ages and rises to a peak at age 18-25 • Emergency department visits are frequently connected to drug effects

3. Investigate / Inquire / Interview

• Support staff can handle paperwork • MRO hands-on attention to non-negatives • Everyone with a *laboratory positive, adulterated, substituted or invalid test must have opportunity to speak with an MRO BEFORE test is verified* Method • Face to face • Telephone (quick, practical)

Oral Fluid: Marijuana (THC and THCA) Detection

• THC trapped in buccal cavity can be detected for the first 12 to 18 hours, maybe as long as 24 to 30 hours. THC and THCA are heavily plasma protein bound - limited transfer to oral fluid from blood. • THCA can be detected by sensitive MSMS technologies (similar to those used in hair testing) and detection window is longer, especially for heavy users • HHS decided to require THC testing at 4 ng/ml for the screening test and 2 ng/ml for the confirmation test Passive exposure • Under extreme conditions it is possible that detectable amounts of THC may be detected. However, as with urine the concentrations remain below the cut-offs.

DOT REPORTING OF RESULTS TO EMPLOYER

• Telephonic reporting to employer authorized Must provide "written" test result to DER or TPA • Use MRO copy of CCF or form letter for reporting results to employer • All test results must include donor name • All non-negative results must by signed by MRO • Cannot report result until MRO copy of CCF has been received and reviewed • All non-negative results must be reported promptly, preferably on the same day as verified by the MRO

TEST CANCELED

• Test canceled always requires MRO remarks explaining why test was canceled A canceled test *cannot be repeated* unless: • A negative test is needed for pre-employment, return-to-duty or follow-up • The employer is required by the MRO to do an immediate recollection under direct observation

Company Policy on Rehabilitation

• The EAP or SAP should have an understanding of the company policy on rehabilitation before evaluating any employee • DOT rules *do not* require employers to provide for rehabilitation of employees who violate DOT rules • An employee who tests positive can potentially lose a job, unemployment compensation or disability benefits if he/she violates DOT rules & or company DFWP policy

Criteria for diluted

• The creatinine conc. is greater than or equal to 2 mg/dL, but less than 20 mg/dL AND • The specific gravity is greater than 1.0010, but less than 1.0030

Specimen Validity Testing (SVT): Federal Employees A urine specimen is reported *substituted* when:

• The creatinine conc. is less than 2 mg/dL AND • The specific gravity is less than or equal to 1.0010, or • Greater than or equal to 1.0200

Oral Fluid: Pharmacology

• Three glands - parotid, submandibular and sublingual • Two types of secretion - serous (water containing electrolytes and amylase) and mucous (mucins) • Oral fluid flow - 0.5 to 1.5 L/day - can be stimulated to 10 ml/min • Wide pH range - 6.0 to 7.8 Incorporation into oral fluid: • Passive diffusion from plasma - dependent upon oral fluid pH (ionized/non-ionized at oral fluid pH), solubility in lipid membranes and degree of plasma protein binding • Only free non-protein bound and non-ionized drug can cross membranes into oral fluid • From the buccal cavity - oral use, smoking, inhalation and insufflation

5. Revel (in Donor Explanations)

• Transmitted sexually or through skin • Deer/chickens grazed on marijuana/hemp • Foreign travel (Mexico, Canada) • Unknowing ingestion (spiked brownies) • Hemp oil cholesterol lowering diet OTC meds: (Advil, Vicks, golden seal tea) • Passive inhalation (rock concerts)

The Medical Review Interview

• Use Standard Checklist (see sample form) • Identify self and affiliation • Confirm identity of donor • "Medical Miranda" warning • Inquire about collection procedures (optional) • Inform donor of result (must specify drugs or adulterant) • Explain verification process • Inquire re: illicit or unauthorized drug use • Inquire re: Rx/OTC drug use and diet • Offer Split Sample • Assess Safety Concerns • Answer technical questions IT IS NOT: • A physician-patient relationship • A popularity contest • A way to build your practice • A criminal investigation • A personal crusade • A tool for use by the employer • A substance use disorder evaluation

Hair Specimen Collection Procedures

• Use clean scissors to cut hair (single use disposable or clean with alcohol wipe prior to use). • Head hair length should be at least 1 ½ inches; approximately 120 strands of hair are needed for adequate sample. • Cut near the rear of the crown and as close to the scalp as possible. • Put the hair sample in the foil packet provided as part of the collection kit, keeping the root end out just about 1/4 inch from the slanted end of the foil. If hair sample is longer than the foil, do not cut the hair sample, but simply wrap excess length around the foil packet. • Place the security seal from the CCF on the bottom of the envelope where indicated. • Instruct the donor to initial and date the seal and envelope after the collector has placed the seal on the envelope. • Collector initials and dates the seal and envelope. • Place the sealed specimen bag into the overnight shipping package and send the specimen to the designated laboratory.

• Methadone and methaqualone:

• Very few (if any) positives

PHMSA (49 CFR Part 199) Pipeline Hazardous Material Safety Admin.

• Written anti-drug and alcohol misuse prevention plans required • Employers must monitor contractor testing programs and submit contractor testing data annually • No random alcohol testing

SAP Follow-up Evaluation

• forms the basis for the employer's decision to return employee to duty SAP must determine if employee successfully complied with the recommendations for rehabilitation • Confer with education and/or treatment professionals • Conduct face-to-face clinical interview with employee • Make clinical determination regarding successful compliance One of two determinations is possible: 1. Employee has demonstrated successful compliance 2.Employee has not demonstrated successful compliance • No return to safety-sensitive duty • SAP can conduct additional follow-up evaluation(s) if employer authorizes • Employer may take personnel action

Criteria for adulterated

• pH is less than 4 or greater than or equal to 11 • The nitrite concentration is greater than or equal to 500 mcg/mL [Note: max for UTI is 125] • The presence of chromium (VI) is verified • The presence of a halogen is verified • The presence of glutaraldehyde is verified • The presence of pyridine is verified • The presence of a surfactant is verified • The presence of any other adulterant is verified

Alcohol Elimination

•1% Unchanged •Breath 0.07% •Urine 0.03% • Sweat 0.10% •Saturation Kinetics • 0.018 % per hour (range 0.005 to 0.03% per hour)

ALCOHOL TESTING PROCEDURES - CONFIRMATION

•15 minute deprivation period required •Confirmation test must be conducted within 30 minutes of screening •Air blank required •EBT must display sequential test number •Obtain breath sample •Result < 0.02 is negative •Result 0.02 - 0.039; employee cannot perform safety-sensitive functions •Result > 0.04 is a violation of rule •Results > 0.02 immediately reported to DER (Designated Employer Representative) •3 copies of printed results

Alcohol Distribution

•Distributes in body water •Men: 55 - 65% of weight •Women: 45 - 55% of weight •Widmark Formula can be used to estimate peak blood alcohol concentration if amount of alcohol consumed is known -- not actually a good idea to work back to time of accident

INSUFFICIENT SPECIMEN PROCEDURES (Alcohol)

•If donor is unable to provide saliva specimen, test must be conducted using breath testing device •If donor is unable to provide sufficient breath specimen after at least 2 attempts: • Use saliva test if it is a screening test & if saliva testing is available, or • Discontinue testing, notify DER (Designated Employer Representative). Donor must undergo medical examination to determine if there is a medical condition causing inability to provide breath specimen. (just like shy bladder procedure)

ALCOHOL TESTING

•No direct MRO involvement •"Confirmatory" testing performed by evidentiary breath instrument •Other specimens (saliva) and procedures can be used for "screening" (procedures have to be NHTSA approved) •Trained technicians perform tests

Breath/Blood Conversion of alcohol

•Separate standards (some states and countries use breath alcohol as the legal standard of presumption) •1 mL blood = 2100 mL air (Henry's Law). Biological variation in this ratio (1:1250 to 1:2800 approximately). •0.10 % w/v = 1 mg/mL blood = 1 mg/2100 mL air

Alcohol Effects Correlate to BAC 0.02-0.05 BAC

•Talkative •Relaxed •Acts self confident •Judgment and movement impaired •Inhibitions reduced

Alcohol Effects Correlate to BAC 0.18-0.30 BAC

•Unable to walk without help •Apathetic, sleepy • Labored breathing •Amnesia of events • Loss of bladder control • Loss of consciousness •Coma •Death

Urine Alcohol

•Urine concentration approximately 1.3 times blood •Usually blood concentration peaks before urine concentration does •Conversion applicable only after concentrations in blood and urine peak •Bladder must be previously emptied (within 1/2 hour) *•Uncontrolled diabetics - high concentrations of glucose can lead to production of significant alcohol after collection by yeast fermentation in non-refrigerated specimens* -- Do POC BG before

ALCOHOL TESTING PROCEDURES SCREENING

•Use EBT (Evidential breath testers) or ASD (Alcohol screening devices) •Obtain breath or saliva sample •Result <0.02 is negative •Result *>0.02 requires confirmation test*

DOT rule Performance of safety-sensitive functions is prohibited:

•While having an indicated alcohol concentration of 0.04 or greater •While using alcohol •Within four hours after using alcohol (FAA rule prohibits alcohol use within 8 hrs of performing safety-sensitive duty for flight crew (pilots, first officers, etc.) Use of alcohol for 8 hours following an accident or until tested, when an employee knows of the accident and an alcohol test is required Refusal to submit to a required alcohol test