drug testing in the workplace presented by dr. ramesh certified medical review officer alliance...

Drug Testing in the Workplace

Presented by Dr. Ramesh

Certified Medical Review Officer

Alliance Occupational Medicine

Substance Abuse in the News

The largest oil spill in over 2 decades in the San Francisco Bay occurred due to substance abuse by the pilot, Capt. John Cota, of a cargo ship. The Cosco Busan's collision with a Bay Bridge tower in 2007 tore a 211-foot gash in the Hong Kong cargo ship, spilling bunker fuel. The Cosco Busan spill oiled 69 miles of shore, closed fisheries and killed more than 2,500 birds.

The NTSB concluded it was caused by Cota's "degraded cognitive performance from his use of impairing prescription medications.“

The National Transportation Safety Board found that Cota had a drunken driving conviction, a history of alcohol abuse and prescriptions for at least nine medications, including Valium; Vicodin; Zoloft for depression; Ativan, an anti-anxiety drug; Provigil for sleep disorders; Imitrex for migraines; and Darvon for pain.

Substance Abuse In the News

The accident was the largest oil spill in the bay since 1988. The Cosco Busan's owner, Regal Stone Ltd., and its operator, Fleet Management Ltd., both of Hong Kong, agreed to pay $44 million to settle the civil case.

Capt. John Coto is currently trying to get his Mariner’s license back, however, the Coast Guard found that Cota "did not meet the medical standards and the professional qualifications requirements for renewal." They issued a final denial in Feb. 2012.

Agenda

Substance Abuse Statistics

What is Reasonable Suspicion?

Signs and Symptoms of Substance Abuse

Components of a Drug Free Workplace Program

Specimen Testing and Confirmation

MRO Role in DOT Testing

Differences in DOT and non-DOT Testing

Alcohol Testing

Alternative Testing

Case Studies


Prevalence of Illegal Drug Use

• Percent of persons 12 years of age and over with any illicit drug use in the past month: 8.7% (2009) and 8.9% (2010)

• Percent of persons 12 years of age and over with marijuana use in the past month: 6.6% (2009) and 6.9% (2010)

• Percent of persons 12 years of age and over with any non-medical use of a psychotherapeutic drug in the past month: 2.8% (2009) and 2.7% (2010)

Source: CDC

Substance Abuse StatisticsResults from the 2010 National Survey on Drug Use and Health

Summary of Findings:

• 2010, Marijuana was the most commonly use illicit drug with 17.4 million current users.

Past month illicit drug use among persons aged 12 or older


Past Month Use of Selected Illicit Drugs among Persons Aged 12 or Older: 2002-2010


Past month illicit drug use among persons aged 12 or older by age: 2009 and 2010

Substance Abuse StatisticsAlcohol Use Among Person Aged 12 or Older

• Slightly more than half of Americans aged 12 or older reported being current drinkers of alcohol in the 2010 survey (51.8%). This translates to an estimated 131.3 million people, similar to 2009, 130.6 million (51.4%)

• Nearly one quarter (23.1%) of persons aged 12 or older participated in binge drinking at least once in the 30 days prior to the survey in 2010. This translates to 58.6 million people, similar to 2009 (23.7%)

• 2010, heavy drinking was reported by 6.7% of the population aged 12 or older or 16.9 million people, similar to 2009 (6.8%)

Definitions:Current Use (past month) –at least 1 drink in the past 30 daysBinge Use- > 5 drinks on the same occasion on at least 1 day in the past 30 daysHeavy Use - > 5 drinks on the same occasion on each of 5 or more days in the past 30 days.


Current binge and heavy alcohol use among person aged 12 or older by age: 2010

Substance Abuse StatisticsDriving under the influence of alcohol in the past year among persons aged 12 or older: 2002-2010


Driving under the influence of alcohol in the past year among persons aged 16 or older: Grouped By age: 2010


Must be base on a reasonable belief that the employee is under the influence of alcohol or drugs on the basis of specific observations concerning the employee’s:

• Appearance• Behavior• Speech• Body odor

Before

After


EXAMPLES:

Worsening of Personal Appearance

• dress, speech, gait, body odor

Decreased Reliability

• absences, late, sick leave, missed deadlines, etc.

Loss of Problem Solving

• Ignores problems, covers up, blames others, etc.

Decrease in Job Knowledge

• Reduced skills, needs supervisor, slow learning, etc.


EXAMPLES (cont.):

Decrease in Productivity

• many breaks, wastes time, does not complete tasks

Poor Judgment

• bad decisions, tactless, illogical behavior, etc.

Difficulty Working with Others

• poor listening and communication skills, hostile, argumentative, etc.

Signs and Symptoms of Substance Abuse

• Odor of alcohol

• Odor of marijuana

• Slurred speech

• Flushed swollen face

• Red or runny eyes or nose

• Pupils dilated or constricted or unusual eye movements

• Lack of coordination

• Tremors, sweats

• Exhaustion, fatigue

• Sleepiness

• Nausea

• Reduced concentration/focusing

• Unauthorized possession of alcohol or illegal drugs

• Any other suspicious behavior

Components of a Drug Free Work Place Program

Issued by President Regan in 1986:

• Written policy regarding substance abuse

• Supervisor training

• Employee education

• Employee Assistance Program

• Methods for identifying drug users

(drug testing)


Purpose of Drug Testing:

• Reduce illicit/inappropriate use of drugs among workers

• Educate workforce managers and employees

• Identify and remove drug users from safety sensitive jobs

• Treat and rehabilitate drug abusers

• Create a deterrent against drug use/abuse


Types of Drug Testing:

• Pre-employment

• Post accident

• Reasonable suspicion/for cause

• Random

• Return to duty

• Follow up to treatment

• Periodic/voluntary


Standards of Practice:

• Federally regulated

- DHHS

- DOT

- DOD

• Non federally regulated

- State laws

- Workers compensation

- Union Contracts


Drug Testing – 3 Steps

1. Specimen Collection

2. Specimen Testing and Confirmation

3. Medical Review of Results (MRO)

Test for:

- Illicit drugs (urine)

- Alcohol (breath, saliva)

- Other specimens (oral, fluids, hair)


DOT Urine Specimen Collection Procedures

1. The collector will ask the donor for photo identification

2. After verification of the donor’s identification, the collector will complete Step 1 of the Custody and Control Form (CCF)

3. The collector will ask the donor to remove any unnecessary outer clothing (coat, jacket, hat, etc.) and to leave hand carried items (i.e. briefcase, pocketbook bags, etc.) outside the toilet enclosure. The collector will secure these items and provide a receipt if requested by the donor. The donor may retain his/her wallet, money clip etc.


DOT Urine Specimen Collection Procedures (cont.)

4. The collector will direct the donor to empty his/her pockets and display the contents. Any items which can be used to adulterate or substitute the specimen must be left outside the toilet enclosure. If the collector believes that any items were brought specifically with the intent to adulterate or substitute the specimen, the collector shall conduct the collection under direct observation.

5. The collector will instruct the donor to wash and dry his/her hands.

6. The collector will provide the donor a wrapped/sealed collection container and specimen bottle (s). Either the collector or the donor may open the container/bottle (s) in the donor’s presence.



7. The collection container and the specimen bottles must be separately wrapped. Only the collection container should be taken into the toilet enclosure. The wrapped bottles should remain outside the enclosure and be opened in the donor’s presence when the donor presents the filled collection container to the collector.

8. The collector will accompany the donor to the toilet enclosure where the donor will provide the urine specimen. The donor will enter the toilet enclosure and shut the door, the collector remains outside the close door.

9. The donor will hand the filled collection container to the collector. Both the donor and the collector should maintain visual contact of the specimen until the labels/seals are placed over the bottle cap(s).



10.The collector checks the specimen, reading the specimen temperature indicator within 4 minutes of receiving the specimen from the donor. The collector marks the appropriate box in Step 2 of the CCF. If the specimen temperature is outside the acceptable temperature range (90-100° F), the collector must direct the donor to provide another specimen under direct observation. The out-of-temperature-range specimen is not discarded.

11.The collector checks the specimen volume, ensuring that there is at least 45 ml. of urine. If the employee is unable to void or voids an insufficient amount of urine, the employee will be provided up to 40 oz. of fluids and up to three hours to provide the specimen. Any partial specimen will be discarded.



12.The collector checks the specimen for unusual color, odor, or other physical qualities that may indicate an attempt to adulterate the specimen. If present, the collector must direct the donor to provide another specimen under direct observation.

13.The collector will pour at least 30 ml of specimen into a specimen bottle (Bottle A). The remainder of the specimen (at least 15 ml) will be poured into a second bottle (Bottle B)

14.The collector immediately places the lid/cap (s) on the specimen bottles, and then applies tamper-evident label/seals (CCF, Step 3).

15.The collector will write the date on the label/seals. The donor will be asked to initial the label/seal (s) once they are affixed to the bottles.



16.After sealing the specimen bottles, the donor will be permitted to wash and dry his/her hands, if he/she do desires.

17.The donor will be instructed to read and complete the donor certification section of the CCS (Step 5), including signing the certification statement.

18.The collector will complete the chain of custody section of the CCF (Step 4), including signing the certification statement, recording the date and time of the collection, and entering the name of the Delivery or courier service (e.g. FedEx, DHL, USPS, LabCorp Courier).

19.The collector will record any remarks concerning the collection process in the “remarks” in Step 2 of the CCF.



20. The collector will place the sealed specimen bottles and Copy 1 of the CCF into the polyurethane bag and seal it. If the specimens are being transported by express or common carrier, the bag is placed in a hard-sided shipping container.

21. The collector will give the donor his/her copy of the CCF (copy 5). The donor may leave the collection site at the completion of this step of the collection process.

22. The collector will distribute the remaining copies of the custody and control form. Copy 2 should be faxed to the MRO listed in Step 1 of the CCF. Copy 3 is retained by the collector for 30 days. Copy 4 is faxed to the Designated Employer Representative (DER) listed in Step 1 of the CCF. If Copy 2 & 4 are not faxed to the MRO and DER respectively, they must be mailed or send within 24 hours or the next business day of the collection.


DOT’s Direct Observation Procedures

1. DOT’s 49 CFR Part 40 directly observed collections are authorized and required when:

The employee attempts to tamper with his or her specimen at the collection site.

The specimen temperature is outside the acceptable range.

The specimen shows signs of tampering unusual color/odor/characteristic

The collector finds an item in the employee’s pockets or wallet which appears to be brought into the site to contaminate a specimen: or the collector notes conduct suggesting tampering


DOT’s Direct Observation Procedures (cont.)

The Medical Review Officer (MRO) orders the direct observation because:

The employee has legitimate medical reason for certain atypical laboratory results or

The employee’s positive pr refusal (adulterated/substituted) test result had to be cancelled because the split specimen test could not be performed (for example, the split specimen was not collected).

The test is a Follow-Up test or a Return-to-Duty test.



2. The observer must be the same gender as the employee.

3. If the collector is not the observer, the collector must instruct the observer about the procedures for checking the employee for prosthetic or other devices designed to carry “clean” urine and urine substitutes AND for watching the employee urinate into the collection container. The observer requests the employee to raiser his or her shirt,

blouse or dress/skirt, as appropriate, above the waist, just above the navel, and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device.

Components of a Drug Free Work Place ProgramDOT’s Direct Observation Procedures (cont.)

The observer requests the employee to raiser his or her shirt, blouse or dress/skirt, as appropriate, above the waist, just above the navel, and lower clothing and underpants to mid-thigh and show the observer, by turning around, that the employee does not have such a device.

If the Employee Has a Device: The observer immediately notifies the collector; the collector stops the collection; and the collector thoroughly documents the circumstances surrounding the event in the remarks section of CCF. The collector notifies the DER. This is a refusal to test.

If the Employee Does Not Have a Device: The employee is permitted to return clothing to its proper position for the observed collection. The observer must watch the urine go from the employee’s body into the collection container. The observer must watch as the employee takes the specimen to the collector. The collector then completes the collection process.



4. Failure of the employee to permit any part of the direct observation procedure is a refusal to test.


Goals of a Forensic Drug Testing Laboratory

To discriminate reliably between those specimens which contain drugs or its metabolite at or above the cut off and those which do not.

To determine specimen validity.

To identify specimens that are substituted or adulterated

To perform these tests in a legally defensible manner.


Initial Test (Screening Test)

Immuno assay test which meets the FAD requirement

Negative Specimen

Any specimen whose apparent concentration of drug or metabolite is less than the pre-established cut-off concentration fore that drug or metabolite.

Not necessarily a specimen containing no drug or metabolite.


Positive Specimen

Any specimen whose apparent concentration of drug or metabolite is greater than or equal to the pre-established cut-off concentration for that drug or metabolite

What is a Cut-Off?

An arbitrary point on a continuum of possible drug or metabolite concentrations.

Use to divide specimens into negatives and positives


HHS Mandated Screening Cut-offs (ng/ml)

• Marijuana Metabolites 50

• Cocaine Metabolites 150

• Opiate Metabolites 2000

• PCP 25

• Amphetamines 500


Confirmatory Test

A second analytical procedure performed on a different aliquot of the original specimen to identify an agent or the presence of a specific drug or metabolite.

Combination of gas chromatography and mass spectrometric analysis GC/MS.


DOT Mandatory Confirmation Cut-offs (ng/ml)

• Marijuana Metabolites 15

• Cocaine Metabolites 100

• Opiate Metabolites 2000

• PCP 25

• Amphetamines 250


Validity Testing

Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine.

The purpose of validity testing 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.

Broad MRO Role In DOT Testing

MRO is the “gatekeeper” of testing process.

Responsible for review of custody and control form for errors (negatives & positives).

Must notify collector or employer when error causes cancellation of test results

Must offer to interview donor with Positive, Adulterated, Substituted and Invalid test results.

Must review “shy bladder” medical findings

Must report medical information to employer when safety or medical qualification is an issue


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

MRO Responsibilities in Regulated Testing (9 R’s; 2 I’s)


Laboratory Reporting to MRO

All test results come from lab to MRO

Cannot go to TPA or employer

Negative results can be emailed without a CCF copy

Lab must report quantitative results on all positive results

Rejected for testing, adulterated and substituted results must include standard explanatory remarks


MRO Review of Lab Negative Results

Review lab results (electronic or CCF)

Review CCF copy 2 for flaws

Check negative on CCF copy 2

MRO staff can conduct review and use signature stamp

MRP must personally review and sign 5% of negatives


MRO Review of Lab Non-negative Results

Non-negative result

Positive adulterated, substituted and invalid

Must have CCF copy 1 with lab scientist’s signature

Review CCF copy 2

Contact and interview donor


MRO Donor Contact Process

MRO must document 3 attempts spaced over 24 hours to contact donor.

After above request, DER to contact donor

DER must document 3 attempts in 24 hours

No part of donor interview may be conducted by MRO staff


The Medical Review Interview

Use standard check list form

Identify self and affiliation

Confirm identity of donor

Explain verification process

Inquire regarding illicit drug use

Inquire regarding Rx/OTC drug use and diet

Donor has 5 days to provide medical use documentation

If there is a legitimate medical explanation, the test is reported as negative


MRO Results Reporting

MRO must review CCF copy 2 before reporting any DOT test results

Negative results may be transmitted electronically

Non-negative results must have MRO’s signature

MRO Record Keeping

Must maintain all CCF copy 2 with signature or stamps with initials

Negatives – 1 year

Non-negatives – 5 years

Drug test results should be separated from patient medical chart because of confidentiality concerns.


MRO’s and Medical Confidentiality

MRO’s are required to release medical information to third party (employer physician, etc.) if the information is:

1) Likely to result in disqualification or

2) Continued performance of the employee’s safety sensitive functions likely poses a significant safety risk

Differences Between DOT & Non-DOT Drug Testing

Tests for additional drugs beyond the 5 drug panel used in DOT

Tests are different (usually lower) cut-offs than the DOT

Single specimen tests rather than split specimen tests

Use of test specimens other than urine

Collection of prescription medication information at the time of specimen collection

Immediate removal of workers from duty pending review by the MRO if they have lab positive results.

Alcohol Testing

No Direct MRO Involvement

Trained Technicians Perform Test: BAT or STT

Alcohol Testing Forms

Standard DOT form (3 copies)

Alcohol Testing Procedures Screening

Use EBT or ASD

Obtain breath or saliva sample

Result < 0.02 is negative

Result ≥ 0.02 requires confirmation test

Alcohol Testing

Alcohol Testing Procedures Confirmation

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

3 copies of printed results

Alternative Specimens

Hair

Use for pre-employment and random

Grows at 1 cm/month or 0.3 mm/day

Oral Fluid and Sweat

Rarely used

Disadvantages

Variation in detection windows

Pharmacology not well known

More expensive

Proficiency testing programs – difficult to establish

Cases

Case #1: Mr. A is an 18 year old male who comes in for pre-employment drug screen which comes back positive for methamphetamines, amphetamines, marijuana, and cocaine. On MRO review, he offers no medical explanation. He states he was at a “party” where there was a bucket and everyone who came in was pouring a lot of “stuff” into it, mixing it all. He drank from it and felt very “fuzzy”. He knew it was a “stupid” thing to do.

Result: Positive for methamphetamines, amphetamines, cocaine, and marijuana.

CasesCase # 2: Mr. B is a 52 year old plumber who came in for pre-

employment drug screen which came back positive for THC. On MRO review, he stated he had a medical prescription for Dronabinol 2.5mg capsules prescribed for appetite stimulation. He brought in his medication. We confirmed his prescription use via “CURES”.

Result: Negative drug screen, however, employer was alerted to be cautious in having him perform “safety sensitive” jobs.

Cases

Case # 3: Mr. C is a 33 year old male who was sent for random drug screen which was positive for cocaine. On MRO review, he stated that he had a “bad tooth” which was extracted and he couldn’t bear the pain so his friend suggested he put some “powdered cocaine” on the area to help with the pain

Result: Positive for cocaine.

Cases

Case # 4: Mr. D. Is a 36 year old male who came in for post-accident drug screen which was positive for THC. On MRO review, he stated he never inhaled or ingested marijuana. However, his room mates smoked it causing his positive drug screen.

Result: Positive for THC

Cases

Case # 5: Ms. E is a 28 year old female who came in for pre-employment drug screen who was positive for THC. On MRO review, she stated she had a “cannabis card” for insomnia and anxiety. Her employer however had a strict “drug free work place policy.”

Result: Positive for THC

Cases

Case # 6: MR. F is a 22 year old male send in for pre-employment drug screen which was positive for amphetamines. On MRO review, he was prescribed (confirmed by me) Adderall for ADHD.

Result: Negative drug screen.

Thank you!

For Additional Resources, go to:

https://nsduhweb.rti.org/

http://www.dot.gov/odapc/employer.html

http://www.dot.gov/odapc/mro.html

Or contact Dr. Ramesh

(408) 228-8400

[email protected]

https://nsduhweb.rti.org/

http://www.dot.gov/odapc/employer.html

http://www.dot.gov/odapc/mro.html

mailto:[email protected]

drug testing in the workplace presented by dr. ramesh certified medical review officer alliance...

Documents

drug testing

past month illicit drug

older slide

marijuana use

psychotherapeutic drug

history of alcohol abuse

nonmedical use

cdc slide