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!

• New (1998) have defined a new category of specimen called "SUBSTITUTED."
Criteria for this category are:
Creatinine is < or = 5.0 AND pH < or = 1.001
Creatinine is < or = 5.0 AND pH > or = 1.020
These 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!
 

• 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"

This paragraph has been replaced by the newer and more complete section which will follow below:
 

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.

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.

 

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"

Click  to  E-Mail  us "tips" or info!      Thanks!
 

• 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!
 

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.
 

• 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!
 

• We recommend using a "punchlist" for this process -- to avoid errors of omission. (Becomes part of record.)
Click Here for a sample punchlist.
• 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.]
 
 

• 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.

• Negative
• Positive
• Non Contact Positive
• Unsuitable
• Canceled
• Refusal to Test ~ Substituted
• Refusal to Test ~ Adulterated

• Such results are described as "not consistent with human urine" and...
• This terminology must appear in both the lab report and the MRO's report!
 

• "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."
 
 

• To Verify and report a positive opiate result, 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!
 

• 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!

• 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!

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 B re-test is the re-test authorized to the donor in "split specimen" testing.
• 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!

 

• 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]

• "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)
• 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]
 

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 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.

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

Click here to view "Management of Verified Positives"
 

• The MRO no longer assists employer in determining schedule of unannounced testing for employees returned to duty following rehabilitation. THIS IS NOW SAP FUNCTION!
• 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.