Announcement: 2017 – 4th of July Holiday Hours

Our office will be closed Monday, July 3rd, 2017 at 5pm through the 4th of the July Holiday. We will return on Wednesday at our normal operating hours.

Happy 4th of July!

THE MRO performs FOUR FUNCTIONS:

RECEIVE lab reports from the laboratory (as governed by regulations)REVIEW lab reports for integrity, authenticity, false negatives, and false positives. INTERPRET lab results, including verification of lab positives REPORT lab results to employers (as defined by rules and regulations.)
THIS SECTION DEALS WITH THE “REVIEW AND INTERPRETATION” FUNCTIONS. TOGETHER, THESE ACTIVITIES ARE KNOWN AS THE VERIFICATION PROCESS!

The best summary of the entire process is:

MEDICAL REVIEW OFFICER MANUAL FOR FEDERAL WORKPLACE DRUG TESTING PROGRAMS

Published and distributed by Center For Substance Abuse Prevention (A division of SAMHSA)  Copies available through CSAP “hotline” at 800-843-4971

MASTER THIS PUBLICATION! …and develop your own “flow chart” to accommodate your system.

The following review of the verification process is based heavily on this publication; but is enhanced to include other documents and guidance, the experience of the author and other readers, and contains revisions required by newer legislation and regulations

RECEIVING LAB REPORTS FROM THE LAB
is covered in detail in a separate section. 
To review this material, navigate to the section called
  Receiving Reports from the Laboratory 

A FEW REMINDERS ARE IN ORDER:

      • The laboratory must report test results to the MRO by secure electronics or by “hard copy.”
      • Test results may not go through employer or third party administrator to MRO.
      • Both Negative AND positive results must be reported to the MRO.
      • Lab MUST send the white “copy 1” of CCF to MRO on all results…
        • if there were flaw(s), the lab SHOULD also send the MFR or Affidavit!
        • Negative results must be certified by lab official (stamp AND initials or signature.)
        • Positive results must be signed by lab’s “Certifying Scientist.”
      • If any quantitative results are given in the laboratory report, employer is not entitled to such quantitative results and they shall not be transmitted by the MRO to the employer.

REVIEW OF TEST RESULTS:

Review of negative results is called “Administrative Review.”

  • the review of negatives can be done by staff  trained and supervised by the MRO.
      • Positive results must be supported by signatures of BOTH donor (CCF copy 2 or any legible copy 2-5) AND certifying scientist (CCF Copy 1.)
      • Positive results demands review of CCF for “fatal flaws.” Non fatal flaws can be corrected by use of signed “Affidavit.”
        • (This document is also known as an MFR or “Memorandum for the Record”)
        • (See the section on “collections” to review the process of correcting CCF errors.)

CRITICAL NOMENCLATURE:

        • Review of negative results carries the simple nomenclature of “REVIEW.”
        • Review of positive results is a totally different process and is referred to as “VERIFICATION.”

VERIFICATION SHOULD ALWAYS BEGIN WITH A REVIEW OF THE CCFOR AT LEAST A FAX COPY!

        • If CCF or a facsimile of it not available REQUEST IT URGENTLY !!!
        • The rest of the verification process is “tentative until the CCF is reviewed!

When seeking a copy of the CCF, remember:

        • The lab copy (1) are useless because they contain no donor information.
        • The Collectors copy (#3) is acceptable because it contains donor phone numbers.
        • Copy 2 (The MRO copy) is really what you need!
        • The donor copy (#5) or Employer copy (#4) will be a suitable compromise, however…
        • Note that going after copy 1 is equivalent to “asking the fox for the chicken house report.
REVIEW: WHO GETS THE FIVE COPIES OF THE CCF?
COPY # DISPOSITION
1 TO LAB… Stays with & documents primary specimen
2 TO MRO
3 TO COLLECTOR
4 TO EMPLOYER
5 DONOR COPY

Now, let’s get to the real work…
THE ACTUAL REVIEW~~ VERIFICATIONPROCESS
INTERPRETATION OF THE LAB RESULTS

WHAT THE MRO MUST MASTER: 

The pharmacology of the drugs being tested for.

      • The  Cutoffs  published by SAMHSA or whoever is governing the testing.
      • The Adulteration (and confounding) issues discussed below.
      • The issues of Validity and Unsuitability
      • The Medical Review Officer Guide referenced above.
      • The “About Drugs of Abuse” pages posted on this website.
      • Be sure you can pass (and understand) the  Self Assessment QuizThis is clickable from the homepage of this website.

SPECIAL RULES AND CONSIDERATIONS

THE UGLY GENERAL RULE:Although the majority of substances in the testing system are straightforward, there are special considerations and special rules for Amphetamines and Opiates.  These will be covered in the following paragraphs.  Note that in addition to the screening and gc/ms confirmation studies, the federal rules provide also for two additional “verification” studies.  They are 6-mono-amino-morphine (6-AM), and Methamphetamine isomers!
SPECIAL CONCERNS IN VERIFICATION OF OPIATE POSITIVES!

The MRO must obtain “clinical evidence” in addition to a confirmed positive
urine test before reporting a test as verified “opiate positive”
THE DEFINITION OF CLINICAL EVIDENCE:

          1. An admission of unauthorized use of an opiate.

[Since “clinical” includes both the history AND physical exam]

          1. A positive test for 6-AM.

[Since 6-AM is specific for heroin… and the results are unequivocal.]

          1. Clear findings compatible with opiate toxicity or withdrawal

on physical exam or face to face mental status examination.
HOW TO IDENTIFY WHICH OPIATE THE DONOR HAS INGESTED?

Do not be deceived by this simply worded heading.
Identifying Opiates is a difficult and inexact science.
Here are some simple rules that will help.  For details, consult your MRO manual(s).

      • Remember that current testing can identify ONLY Morphine, Codeine, Heroin, and Poppy seeds.  (Not kidding!)
      • The cut-offs and rules are designed to eliminate the innocent poppy seed user.

[As a result, a few heroin addicts and/or Morphine/Codein abusers get “excused” by the cut-offs and rules]

      • Codeine metabolizes to Morphine!
        • Some Codeine is excreted unchanged into the urine.
        • Codeine is therefore found in the urine as both Codeine AND Morphine (its metabolite.)
      • Morphine never metabolizes to Codeine!
      • Remember that the “synthetic opiates” are NOT identified by current testing protocols.

[Hydrocodone, Oxycodone, Dilaudid, Demerol, etc. do NOT metabolize to Morphine.]

      • The poppy seed claim can be “verified” using the “quants.”  [There is seldom very much Codeine in poppy seeds!]
        • Poppy Seeds follow the “ElSohly Rule”… M/C>2.
        • This means that the Morphine/Codeine ratio will always be more than 2.
        • If M/C is less than 2, this confirms a source of Codeine OTHER THAN poppy seeds!
        • In “real life,” poppy seeds contain VERY LITTLE Codeine, so M/C will be a 2 or even 3 digit number.
      • It is extremely rare to see morphine quants above 2,000 ng/ML from poppy seed ingestion!

This is why the opiate cutoff level was recently raised from 300 to 2,000 ng/mL.

      • 6-AM [6-mono-acetyl-morphine] is specific for heroin… but is low titre and volatile and often “missed.”
        • Therefore remember the following two facts about 6-AM:
          • A positive 6-AM is unequivocal evidence of heroin use… however,
          • A negative 6-AM is meaningless… it does NOT rule out heroin use!
      • Heroin is Di-acetyl-Morphine.  There is NO CODEINE in heroin!
      • Furthermore, Heroin does not metabolize to Codeine!
      • Most heroin on the street today is quite “pure”… but may (rarely) be “cut” or adulterated… even with Codeine.
        • Expect to see hi levels of morphine, and (maybe) 6-AM but seldom Codeine in the urine of Heroin users.
        • If Codeine is found in the urine of a heroin user, it is an adulterant or was ingested separately!

IS A PHYSICAL EXAM REQUIRED BY THE RULES?

    • Answer:  NO!  Nowhere in the regulations or guidance is it specified that a face to face interview and/or exam MUST be conducted whenever the finding of opiates in the urine are still unexplained following the MRO’s interview and or evaluation of verification studies (quants and 6-AM.)
    • Given this fact, and the ideas below, the alternative to ordering an exam is to report all opiate positives to the employer as “negative” unless the donor admits unauthorized use of opiates or the 6-AM is positive.
    • In some quarters, this is “standard procedure.”

IF THE RULES REQUIRE CLINICAL EVIDENCE, THEN WHO SHOULD HAVE AN EXAM?

      • As of 1998, the new 2,000 ng. cut-offs will eliminate many donors for whom this decision had to be made in the past!
      • This must be decided on a case-by-case basis using the following facts & background:
        • Nationwide, it seems to be a “fact of life” that the “yield” from these exams is nearly zero.
        • This means that it is extremely rare for these exams to yield “clinical evidence.”
        • The higher the Morphine level, the more likely it represents heroin use.
        • The lower the Morphine level, the more likely it represents poppy seed use.
        • Unfortunately, to report these cases (opiate positive, 6-AM negative) as “negative” without an exam is to allow a donor to remain in a safety-sensitive position without pursuing the (remote) possibility that an exam might identify a donor with a serious substance abuse problem.

A GOOD “COMPROMISE POLICY” MIGHT BE:

        • If the quants are high and the logistics are reasonable, by all means, order an exam!
        • If the quants are low and/or the logistics are prohibitive, report the results as “negative.”

LET’S SAVE OUR BREATH AND OUR PAPER:

        • This whole issue of verifying, interpreting, and reporting of opiates is highly controversial!
        • A further discussion is beyond the realm of this work and shall not be attempted!
        • A good and short summary of the face-to-face exam for opiate positive donors follows below:
CLINICAL EXAM FOR OPIATE POSITIVES            -from H. Westley Clark, M.D., J.D., M.P.H.  SIGNS AND SYMPTOMS OF OPIOID INTOXICATION:     Euphoria, Drowsiness, Respiratory Depression, Constricted Pupils, NauseaSIGNS AND SYMPTOMS OF OPIOID OVERDOSE:     Slow and shallow breathing, Clammy skin, Convulsions, Coma, DeathSIGNS AND SYMPTOMS OF OPIOID WITHDRAWAL:    (Note: All withdrawal symptoms are parasympathetic) Watery eyes, Runny nose, Yawning, Loss of appetite, Irritability, Tremor, Panic, Cramps, Nausea, Chills and sweating
PHYSICAL SIGNS OF INJECTION DRUG USE:

    • Track marks along veins:
    • Usually in antecubital fossa. Men may hide on lateral arm surface (if hairy) May be obscured by tattoos. May be on legs, dorsal feet, behind knees. May even be between toes, dorsal penis, or other occult sites.
    • Signs of recent needle injection sites:
    • If good skin hygiene, poor chance of finding pock marks or abcesses….. but may find recent injection. If hygiene poor, may find pock marks, abcesses, or chronic induration over veins.

“UNAUTHORIZED” USE OF OPIATES INCLUDES:

        • Use of illicit opiate substances.
        • Unauthorized use of prescription or medically dispensed opiates… or
        • Use of opiates obtained in a foreign country without valid U.S. prescription.
        • “Authorized” means a U.S. prescription in the donor’s name!!!
          • “SPOUSAL USE” is no longer a legitimate excuse! though many MRO’s are “conscientious objectors” to this Federal guidance and do excuse donors for verified “spousal” or “intra-family” use.

SPECIAL NOTE:

        • The MRO may make a “blanket request” to lab for quantitative levels on morphine & codeine.
        • Quantitative results for all other substances must be requested in writing on a case by case basis.
        • NOTE that as of 12/1/98 a 6-AM assay will be done automatically on any Opiate-positive specimen [above the new cut-off of 2,000 ng/mL.]

SPECIAL CONCERNS IN VERIFICATION OF AMPHETAMINE POSITIVES!NOMENCLATURE:
This is a special problem with the amphetamines and is resolved by noting the following:

        • The word “Amphetamine” refers to this entire class of drugs.… however… be careful…
        • There is also a specific (sub-category) of substance called “amphetamine.”
        • “methamphetamine” is also a “sub category” of “Amphetamines.”

BASIC FACTS:

      • The current testing protocol identifies only  two drugs of abuse:  amphetamine and d-methamphetamine.
      • Methamphetamine metabolizes to amphetamine.
      • amphetamine DOES NOT metabolize to methamphetamine in vivo!
      • Authorized testing in the current protocol includes ONLY:

amphetamine, methamphetamine, and methamphetamine isomers.

      • Do not get confused: When you order “Amphetamine isomers,” you get “methamphetamine isomers.”
        • If you’re still confused, resolve your confusion this way:
        • Methamphetamine is the only substance (in the “Amphetamine class”) for which an isomer assay is authorized.
      • “Designer drugs” [MDA, MDE, MDMA, etc.] even though Amphetamine analogs, are not identified with current tests!
      • In addition to the isomers, there is an additional special problem, i.e. “factitious methamphetamine:”
        • “Factitious methamphetamine” can be generated (from hi dose ephedrine & possibly other sources) in the gc chamber during confirmation.
          • To summarize the “fix” for this problem:
          • A positive methamphetamine requires at least 200 ng/mL of amphetamine!
          • This is IN ADDITION to the cut-off requirement of 500 ng/mL of methamphetamine!
        • MRO’s must be familiar with this problem which can be reviewed in the section on amphetamines.
      • REMINDER:  The MRO should request D & L isomer analysis on methamphetamine positives when the donor denies methamphetamine use or claims Vick’s Inhaler use!

THE VALIDITY ISSUE:

New (1998) have defined a new category of specimen called “SUBSTITUTED.”DILUTE SPECIMENS:

Criteria for this category are:Creatinine is < or = 5.0 AND pH < or = 1.001
Creatinine is < or = 5.0 AND pH > or = 1.020These can be thought of as “super dilute”
Such specimens are “not consistent with human urine”…and this nomenclature will be included in the report from the lab on such specimens!

      • The older category of “DILUTE” will now have the following criteria:

Specific gravity between 1.001 and 1.003   AND Creatinine less than 20 mg%.
The MRO will report these as “Negative and dilute” OR “Positive and dilute.”
Employer may require donor to provide subsequent specimen under direct observation.(NOT NOW, BUT on the next occasion that employee “comes due.”A dilute specimen is not “reasonable suspicion” to require another specimen.

  • A negative result is valid, even if dilute!

UNSUITABLE SPECIMENS:  (“unexplained” VS. “explainable”)

      • Interfering agents — e.g. Non steroidal anti-inflammatory prescriptions, metronidazole, ciprofloxin or others.
      • The term “unsuitable” is applied when a valid immunoassay result is not achieved (abnormal high or low readings) or pH out of normal range, but the presence of adulterants is not substantiated.
      • Interfering agents, e.g. NSAID’s, metronidazole, ciprofloxin or others, might occasionally explain the unsuitability.
      • MRO ACTION: Discuss with lab’s chief scientist. Contact donor and inform that specimen was unsuitable. Ask especially about NSAID’s or other explanations.
        • If no explanation, MRO reports final result of  “UNSUITABLE.”

inform donor and employer that another specimen will be collected under direct observation.

      • If there is an acceptable explanation for the unsuitability, the MRO reports the result of  “CANCELED”

ADULTERATED SPECIMENS: This paragraph has been replaced by the newer and more complete section which will follow below:

TEST BUSTING 101: IN FOUR PARTS

A brief summary of the four methods of circumventing the testing process:At the risk of “helping” the drug abusers who monitor this website, we present:

    1. DILUTION: A prevailing “motto” among “test busters” is “The solution to polution is dilution.”

Physiologic dilution is the basis of the most common types of commercial “test busters.”  Most of them work not because of their “active ingredient,” but rather because of the accompanying directions to force fluids.
Surreptitious dilution refers to the act of “dipping” to dilute one’s specimen with toilet water… or “sneaking” an aliquot of water into the collection area and adding it to one’s specimen.

    1. SUBSTITUTION:  There are two common means for a donor to present a “substituted” specimen.

Dipping:  Refers to procuring one’s specimen from the toiled bowl.  With the 1998 rules revision, these specimens will almost invariably be identified by the lab and reported as “Substituted ~ Refusal to Test.”
“Fictitious Urine:”  In this method, the donor purchases a commercial “clean urine” product or procures a “substitute specimen” from a co-operating” non drug user and presents this in lieu of his/her own urine.

    1. ADULTERATION involves the donor’s addition of a “confounding” substance to his/her urine specimen.  Such substances can be purchased commercially, or may be common household chemicals.  [See the section below on adulteration.]
    2. SPECIMEN THEFT:  To “steal” one’s specimen while the collector’s back is turned [or otherwise prevent the specimen from getting to the laboratory] is probably the boldest and most malicious means of “beating” a drug test… and yet it is the most effective!

ADULTERATION:

      • Many “commercial” adulterants are marketed… especially to the “Marijuana community.”
      • These are affectionately called “test busters” or “test beaters.”
      • Some work… some are hoaxes!
      • The table below will list some common adulterants both “home made” and “commercial”
TRADE OR HOUSEHOLD NAME ACTIVE INGREDIENT MECHANISM REMARKS
Glutaraldehyde Glutaraldehyde Binds proteins in I/A Labs all “wise” to this
UrinAid Gludaraldehyde
Mary Jane Super-Clean 13 Clear liquid soap
Urine Luck Pyridinium chlorochromate Oxidizes THC metabolites Affects both I/A and gc/ms
Klear Potassium Nitrite Oxidizes THC metabolites Affects both I/A and gc/ms
Joy & other clear liquid soaps
Visine Surfactant (?)
Bleach H+Cl Lowers pH to disable I/A
Salt Salt Distorts I/A readings
Vinegar Acetic Acid Distorts I/A readings
Body Flush Seeking info “Dilution” principle! Probably a hoax
Whizzies Sodium Nitrite
Powdered Urine None Substitution principle This is “collector issue.”
Soda [Mt. Dew /Pepsi, etc.] Carbonic acid (?) Lowers pH to distort I/A Other parameters “pass.”
Golden Seal (tea) Probably none “Dilution” principle! Probably a hoax
Herbal Klean Master Tea Probably none
Test-Free  (Zydot Unlimited) Probably none

READERS…!!!   Please help us complete and maintain this table of adulterants.

MRO ACTION is required for substituted, adulterated and unsuitable results!

      • Forensically validatable “adulterated” results are reported as “Refusal to test!”
      • “New” (1998) result of “substituted” is also reported as “Refusal to test!”
        • These have almost the same impact of a “positive” test PLUS the implication of “donor deception” by attempting to circumvent the testing process!
        • The lab does not perform drug tests if they find adulteration or substitution, so there are no actual “results,” however
        • Both of these “Refusal to test ” results indicate “cheating” and are forensically defensible!
        • These donors “lose” their right to a “bottle B” retest.
        • The MRO is NOT required to conduct an interview with these donors since:
          1. There are no possible “legitimate explanations” for these results… and
          2. There are no “rights to preserve” or advise the donor of!
      • “Explained unsuitables” are reported as “canceled”
      • “Unexplained unsuitables” are reported as “Unsuitable”

These require a new witnessed collection!
SOME “OPTIONAL” TRICKS FOR THE “ADVANCED:”  (For “Unsuitables”)In cooperation with your lab’s certifying scientist, there are two options to pursue with unsuitable specimens:
As “background”

        • Remember that adulteration is always a primary suspicion when trying to “identify” what is causing unsuitability!
        • Remember that unsuitability implies that the lab cannot identify an adulterant, but includes adulteration in the list of possible explanations.
        • An MRO interview might occasionally reveal an “interfering” medication; but usually will leave the issue unresolved.

THE OPTIONS ARE:

      1. The first option is to try a different immunoassay.
        • This option is available in all programs, including those which are federally regulated!
        • RIA is the “most rugged” but not always available.
        • There are others!  Check with your certifying scientist!
      2. The second option is to proceed directly to a gc/ms assay.
        • This option is “against the rules” in federally regulated programs.
        • This option is expensive and requires “guessing” at which substances to test for!
        • In unregulated testing, there is nothing (other than expense) to preclude the MRO and Certifying Scientist from employing the strategy of proceeding sequentially through gc/ms assays for each of the various substances … expecting to find what the donor was trying to “hide” by adulterating the specimen.

DILUTE SPECIMENS:  WHAT ACTION TO TAKE!

      • As emphasized elsewhere, Dilute specimens are valid under DOT rules!
      • “Negative-dilute” specimens become part of the donor’s record and suffice for assignment to safety sensitive duty!
      • The rules do not require a retest... but give the employer the option to witness the next collection.
      • Individual company policies (even if governed by DOT) may write stricter policies… i.e.
      • To require another collection in the event of a “dilute” report may be justified by a recent study:
        • MEDTOX STUDY: 7,700 specimens were studied over 18 months.
        • Dilution was DOT definition, i.e.  Sp.Gr. < 1.003  AND  Creatinine < 20 mg.%.
        • Fact one: Dilute specimen submissions over the 18 months increased from 3.2%  to 4.6%.
        • Fact two:   9.1% of the dilute specimens contained detectable cocaine or marijuana!
      • This confirms the wisdom of companies who require “re-collection” and “retesting” of donors with “dilute” results.

CAVEAT:
Because Federal rules do not authorize such re-collections and “repeat tests,” DOT regulated companies, must carry out such re-collections & tests on NON FEDERAL CCF’s and protocols unless and until Federal rules are changed to require such retesting!

INTERVIEW WITH “LAB POSITIVE” DONOR: 

THE PRIMARY PURPOSE OF THE MRO/DONOR INTERVIEW
            is to determine if there is an alternative (legal) explanation for the urine test results.

      • We recommend using a “punchlist” for this process — to avoid errors of omission. (Becomes part of record.)
      • Note especially the checklist [repeated in the graphic below.]
 ~ NOW HEAR THIS ~ 
 
THE FOLLOWING ITEMS MUST BE IN THE MRO’S HANDS BEFORE THE INTERVIEW WITH A LAB-POSITIVE DONOR!

  • The actual laboratory report — or a legible copy thereof
  • Legibly signed Copy 4 of the CCF — or a copy thereof
  • White “Copy 1” of the CCF, signed by Certifying Scientist
  • Verified authenticity and integrity parameters.  (Identifying data)
  • Donor must be asked if s/he is satisfied with telephone security!

The MRO must conduct a medical interview with EVERY DONOR on every lab-positive result! THIS IS THE “CARDINAL RULE” and is clearly spelled out in DOT and other Federal guidance!

  • Q. May this interview be delegated to an MRO assistant?
  • A. NO!  The MRO assistant may perform only the following portions of the lab-positive donor interview.
    • Assemble and prepare the documents listed above and expedite donor-MRO contact.
    • Contact the donor.
    • Document the donor’s “claim.”
    • Verify prescriptions or other medical history given to support the donor’s claim.
    • Process a case in which a verified donor claim represents a valid explanation for the positive lab findings.
    • Process a case where the donor “admits” abuse of a substance and refuses to complete the process by speaking to the MRO after being told that s/he is supposed to do so.
    • Assemble and prepare the MRO’s report to the employer following an MRO/donor interview which results in an MRO-positive result.
    • Assemble and prepare documentation of a positive result for the MRO’s files.

EXCEPTIONS… i.e.

WHEN CAN A POSITIVE TEST BE REPORTED WITHOUT AN MRO INTERVIEW?

  • If donor refuses to discuss the results. (This is grounds to report the test “MRO POSITIVE!”)
  • If donor proves difficult or “impossible” to find. (see: Section 382.407)
    • A.   MRO should make every reasonable effort to contact the donor using the information on the CCF.
    • B.   If this fails, “MRO reports to the employer that he has made all reasonable efforts to contact the donor as provided in 40.33(c) and has been unsuccessful.
    • C.  The employer shall, “as soon as practicable, request the driver contact the MRO prior to dispatching the driver or within 24 hours, whichever is earlier” (as confidentially as possible). The employer should notify the MRO when the donor has been advised of the requirement to contact the MRO. [A “five day clock” is begun at this point.]

D.  MRO may issue the report of “non contact positive” if the donor has not contacted the MRO after the “five day clock” has expired OR if neither the MRO nor the employer has been able to reach the donor after making reasonable attempt for a period of 14 days [from the date the MRO receives the confirmed lab report.]

THE ACTUAL MRO/DONOR INTERVIEW:

  • We recommend using a check list for this interview —
  • The check list also becomes part of the record.

Click here to review a sample MRO Interview Check List
To learn the Interview technology, the best means is to study the check list!
There are no short-cuts or “tricks.”

CRITICAL REMINDERS:
The MRO must inform the donor of the “limits of confidentiality” in the medical interview.

  • Limit One is that the donor’s report must be released (confidentially) to the designated employer representative.
  • Limit Two is that the immediate supervisor will almost invariably be told of the reason for any action taken.
  • Reassure donor that the results are not released to law enforcement or courts.
  • Reassure donor that the results are NOT released (by name) to the DOT.
  • If a CDL holder, reassure donor that no one has the authority to “take away” his/her CDL.
  • Reassure donor that neither the MRO or the employer may release the test results without the express written consent of the donor.

The MRO may disclose medical information (without donor consent) if:

  • Donor may be medically unqualified under D.O.T. standards….or
  • Donor may present a serious danger to public safety based on information provided.

FINAL CATEGORIES OF RESULTS:

 As of September 28, 1998 …as a result of SAHMSA document PD #035, and corroborating guidance from DOT, the categories and nomenclature of test results have been re-defined and are as below.

THE SEVEN RESULTS CATEGORIES:  (They will be “recited” here… and then defined and explained)

      • Negative
      • Positive
      • Non Contact Positive
      • Unsuitable
      • Canceled
      • Refusal to Test ~ Substituted
      • Refusal to Test ~ Adulterated
“NEGATIVE” TEST: (SELF EXPLANATORY!)   The review done here by the MRO (or delegated to MRO staff) is called an “administrative Review.” It is, however, an IMPORTANT review, because some “lab negative” tests will be INVALID tests or FALSE NEGATIVES!
“POSITIVE” TEST: (NOT SELF EXPLANATORY!)
The result of “positive” can be declared ONLY after a long & intense verification process requiring time and expertise!      The nomenclature summary of this process is:   
Screening >>>>>>>>>>> “presumptive lab positive”   GC/MS Confirmation >>>>>>>>>>> “lab positive”  Verification >>>>>>>>>>>>>>>>> “MRO positive” 
“NON-CONTACT POSITIVE” AND “UNSUITABLE” RESULTS:     These categories are defined in the preceding sections! “CANCELED” TEST  
is reported in the following cases:  

  1. Primary specimen (“Bottle A”) is found to be “unsuitable.” UNSUITABLE SPECIMEN = (suspected but not proven adulteration) This may be due to an “explainable” cause such as NSAID’s etc.
  2. Split specimen is found to be “unsuitable” AND a retest is requested.
  3. Uncorrected or uncorrectable “fatal flaw” occurs on C.O.C. form.
  4. Test results are felt to be “scientifically insufficient” — for whatever reason.
  5. Split specimen (“bottle B”) is not available for testing AND a retest is requested.
  6. Split specimen is found to be not adequate (insufficient volume) for testing AND a retest is requested.
  7. Retest results (Bottle B) do not confirm initial results (Bottle A.)
IMPLICATIONS OF A “CANCELED TEST.”    (Is a re-test called for?)  

  • The word “canceled” does not always mean the donor is “off the hook!”
  • Each situation calls for it’s own course of action …. and some MRO judgment!
  • The following is a summary of what DOT requires: (referring to numbers above)
MRO ACTION REQUIRED BY A “CANCELED TEST:”  [Numbers refer to nubered list above]

    • 1 & 2. Although a specimen unsuitable for “explainable” cause requires no action and the donor may be left “off the hook,” any unexplained unsuitable specimen requires a re-test with a WITNESSED COLLECTION!
    • 3. Every attempt should be made to correct a correctable flaw on the C.O.C. form before declaring the test “canceled.” If the flaw is uncorrectable, the MRO may declare the test “canceled” without further action, leaving the donor “off the hook” (except for those cases where a “negative” test is called for*)
    • 4 thru 7. In each of these cases, the MRO may declare a test “canceled” without further action. Again, the donor is “off the hook” (except for those cases where a “negative” test is called for*)

*In cases of pre-employment, return to duty, and follow-up drug testing, drug testing, a test which is declared “canceled” will have to be repeated because of the DOT requirement for a NEGATIVE TEST!

Although some employers have a policy of responding to all “canceled” tests with a re-test.  As explained above, this may be a wise policy, but they are NOT doing so because federal rules require it!  
“ADULTERATED” SPECIMEN:      New 1998 Definitions of “Adulterated” are: 

    1. Lab finds Nitrite > 500 micrograms/mL
    2. Lab finds pH < or = 3.0
    3. Lab finds pH > or = 11.0
    4. Lab finds a biologically normal substance in a biologically ABNORMAL concentration.

Lab finds a definite (defensible) adulterant!

“SUBSTITUTED” SPECIMEN:
THIS IS A NEW CATEGORY OF RESULT (1998) 
A specimen is “substituted” if:  

  1. Creatinine is < or = 5.0 AND pH < or = 1.001
  • Creatinine is < or = 5.0 AND pH > or = 1.020
  1. Such results are described as “not consistent with human urine”and…
  2. This terminology must appear in both the lab report and the MRO’s report!

 
REMINDER:
IF A SPECIMEN IS ADULTERATED OR SUBSTITUTED, The new (1998) guidelines give the following directives:

  • “Quants” for validity tests will not be routinely reported, but may be forwarded to MRO upon request.
  • The donor no longer has the right to a Split Specimen (Bottle B) retest!
  • The lab shall NOT report the test as “negative”
  • The lab shall NOT report the test as “positive” even though the lab may proceed with testing of the specimen (for internal or scientific reasons.)
  • As will be seen, these specimens are reported to employers as a “refusal to test” …which has the impact of a “positive” test PLUS the additional implication of “donor deception” in attempting to circumvent the testing process!
  • There is NO REQUIREMENT for the MRO to interview these donors…however,
  • Some employers are “balking” at the responsibility of being the first person to advise the donor of his/her results.
  • In general, employers do not understand the meaning of these results, and more education is needed!
  • For these reasons, it is not only courteous, but often necessary to interview these donors. [It’s also interesting!]
  • If the MRO decides NOT to interview these donors, there probably should be an assertion to that effect in the report to the employer, even though not required by the rules!

e.g.: “Regulations no longer require the MRO to interview donors with this test result.  Consequently, the MRO may MAY NOT HAVE done so prior to releasing this report.”
TWO MORE CRITICAL REMINDERS:

  • To Verify and report a positive opiateresult, there must be CLINICAL EVIDENCE of abuse!
  • For ALL Positive results, VERIFICATION IS NECESSARY!
    • 90% of the MRO’s time, energy, and expertise will be used in the VERIFICATION process. This is the function which requires “art,” the skills and the mind-set that only an experienced physician can best bring to bear!

ANOTHER “CAVEAT” ABOUT NOMENCLATURE:

  • CONFIRMATION is the term used for the laboratory procedure of using gc/ms studies to confirm that a positive immunoassay was truly positive
  • VERIFICATION is the term used to describe the function of the MRO in reviewing the lab results, interviewing the donor, and interpreting all available bioinformation to VERIFY that a positive test truly indicates substance abuse!

Use these terms correctly,….. or expect possible misunderstandings!

CONFIRMATION occurs in the laboratory…..  VERIFICATION is carried out by the MRO

FORMAL VERIFICATION OF TEST RESULTS:

      • Documentation of Verification is required for BOTH NEGATIVE AND POSITIVE results:
      • MRO MUST SIGN verification statement at bottom of CCF form on ALL VERIFIED POSITIVES!
      • MRO or MRO-trained delegated staff must sign MRO verification statement on CCF on all NEGATIVES!
REPORTING VERIFIED RESULTS TO EMPLOYER
is covered in detail in a separate section. 
To review this material, navigate to the section called
 Reporting Results to Employers 

RE-TESTING FOLLOWING A POSITIVE TEST:

A “bottle B re-test is the re-test authorized to the donor in “split specimen” testing. 
NOMENCLATURE: In most federally regulated testing programs, split specimens are collected, but (at the option of employers) there are some government agencies [e.g. RSPA and the U.S. Coast Guard] and some companies whose employee-donors (even though given the right to a re-test in the event of a positive test) do not collect “split specimens.”  In these cases the “re-test” is done on the primary specimen, “bottle A.”    Although this author has not experienced any problems with this nomenclature, some professionals in the DFW field seem to think there are nomenclature problems.  Therefore, consider the following:

  • A “bottle A re-test” exercises the same donor right in a testing program where there are no split specimens.
  • A “re-test” (with no “bottle” specified) refers to the donor’s right to “challenge” the lab following a positive test… referring to one of the two systems above.
  • “Re-test” never means collecting another specimen and sending it for testing as a means of re-evaluating the donor’s compliance with the Drug-Free Workplace rules.  No such rights have ever been defined in any regulations anywhere at any time!

REPORTING SEQUENCE:  This is “rule one”

  • The donor’s right to a “re-test” must never be construed or carried out as a means to “buy time” before the verified “positive” report is forwarded to the employer!
  • The MRO must not withhold the “positive” report from the employer pending a re-test!
  • The donor must be removed from safety-sensitive duty while awaiting the re-test results.
  • In those RARE cases where the re-test fails to confirm:
    • MRO will pronounce “canceled test” and
    • The employer must re-instate donor!

THE SEQUENCE IS:
Screen > Confirm > Verify > REPORT > [Retest]                  [Donor must be removed from safety-sensitive duty during the retest process!]

THE RE-TESTING PROTOCOL:

    Some critical reminders

  • “Bottle A” is property of employer!
  • “Bottle B” is the property of the donor!
  • If not mandated by regulation, whether to collect split specimens is the decision of the employer!
  • The donor has 72 hours to request a “bottle B” re-test.  (or Bottle A if not a split collection)

(72 hours from the time donor is notified that Bottle A is positive — and for which substance)EXCEPTION: Pipeline and Aviation employees have 60 days to make request!
NOTE: In the “real world” MRO’s are often “lenient” regarding this waiting period… if for no other reason, because there is concern regarding a “refusal” to order a re-test when requested.

  • The request must be made through the MRO.
  • The donor’s request DOES NOT HAVE TO BE IN WRITING ….. however….

The MRO must “relay” the request IN WRITING!
(Staff may be trained for this!) (Currently, a fax or electronic request is thought to be just fine!)

  • Employer MAY (usually does) insist that the donor pay for the cost of re-testing!

Remember that this is a gc/ms test and costs about $100 or more.

  • 1997 guidance from DOT falls short of “requiring” employer to pay for Bottle B test, but states clearly that the employer’s refusal to pay should never be the reason a donor was denied his right to a Bottle B re-test.
  • Re-testing must be done in a different lab… which must also be SAMHSA certified.
  • Cutoffs do not apply to a “Bottle B” re-test… or a “Bottle A” (single specimen) Re-test!

The rule on re-tests is: “If ANY analyte is found, the test is confirmed positive.”
The “testing protocol” calls for testing at the LOD.  (limit of detection)

    1. If the “re-test” does “re-confirm” the metabolite found in the primary specimen, the MRO must notify both the donor and employer… regardless of who has paid for the re-testing.

 

  • IF THE “RE-TEST DOES NOT “RE-CONFIRM” for the metabolite found in the primary specimen:
    • The MRO reports a “canceled” test!
    • Although extremely rare and unlikely, this always causes MAJOR UPHEAVAL!
    • Be ready to exercise your very best “damage control skills.”
    • Any failure to reconfirm must be reported to the donor, the Employer, and the DOT regardless of who paid for the test.
  • CANCELED TEST” will also be reported if:
    • Split specimen (“bottle B”) is not available for testing
    • Split specimen is not adequate for testing….. or
    • Split specimen is untestable. [See “page” entitled “About the MRO” for full dissertation on “Cancelled” tests]

SPECIAL (Test Question?) SITUATION:

What does the lab do when they notice that no “Bottle B” has been submitted? The answer to this question is not a judgment call or matter of MRO opinion!  Clear guidance has been issued to the laboratories that when bottle A is submitted and suitable for testing, they are not to mention the absence of a “bottle b” or call it to anyone’s attention.   The lab will proceed to test bottle A and report their findings as usual.   It is only if and when the MRO notifies the lab that a donor has requested a “bottle b” re-test, (after his interview with the MRO) that the lab “announces” that there is NO BOTTLE B!     This does happen occasionally; and, unfortunately, it often happens AFTER the MRO has already reported the “positive” result to the employer!  The MRO then must notify the employer that the report must be “ammended” to “canceled” because of technical reasons.  Once again, we have a situation that causes major upheaval and the need for damage control, because:

    • The employer has already been told what substance the lab found!
    • Quite possibly the donor may have been fired already… and now must be reinstated!
    • The employer’s trust in the testing system may be eroded by such an event

MRO RECORDS-KEEPING:

WHAT THE MRO SHOULD KEEP

  • MRO copy (pink) of Custody and Control form.
  • LAB copy (white) of Custody and Control form.
  • Medical (donor) interview documentation.
  • Documentation of Verification punch list including any verification contacts (physician, pharmacy, hospital, etc.)
  • Documentation of employer notification.
  • Documentation of “final verification” of results.
    • This would be either the signed MRO certification statement at bottom of pink CCF)  or…
    • It’s equivalent in a letter or proprietary document.

HOW LONG MUST THE DOCUMENTS BE KEPT?:

  • Five years for positive results!
  • One year for negative results.

POST-REHAB OR “FOLLOW-UP” TESTING:

The MRO no longer assists employer in determining schedule of unannounced testing for employees returned to duty following rehabilitation. THIS IS NOW SAP FUNCTION!Click here to view “Management of Verified Positives”
NEW RULESFor post-treatment “Relapse Prevention” Programs:

  • Documentation must be kept on file for EACH AND EVERY follow-up and RTD test result.

Follow-up testing is in addition to employee being in random pool!

COMMON  MRO  ERRORS 

    • Inappropriate “Downgrades” of Positives
    • Inadequate Documentation of Medical Interview (with donor)
    • “Blanket authorization” for Quantitative levels
    • Notification of Employer before donor contact completed
    • MRO not identified on custody and control form
    • Results not transmitted to MRO
    • No Administrative review of results
    • Dilute specimens canceled; Re-collections ordered.
    • Dilute specimens are valid!
    • “Poppyseed” claim not verified or “challenged” resulting in “false negative” report!
    • No “CLINICAL EVIDENCE” documented for Opiate verifications.
    • No follow-up testing documentation on RTD employees
    • Inappropriate handling of “Split” or “Reanalysis” request

FLOW SHEETS

Many “Flow Sheets” “Decision Trees” are available — M.R.O. Course handouts are good; but the best one will be the one you make for yourself and your staff based on your own experience and your way of training and delegating in your organization.