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!

This section is devoted entirely to the “new” 1998 rules for reporting “Re-test” results. The new nomenclature is defined and explained for these results from lab to MRO and from MRO to employer.


THE RE-TESTING PROCESS

[“Bottle B” testing]

REVIEW OF THE RULES FOR RE-TESTING:

NOMENCLATURE: In most federally regulated testing programs, split specimens are collected, but (at the option of employers) there are 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!

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 cutoff is known as 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]

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

~Under Construction ~

In September 1998, HHS issued PD #035 which addresses the issues of adulteration and substitution of specimens and calls for a change in the Nomenclature and Mechanics of reporting test results.

Due to the changes mandated by DOT’s PD #O35 the following preliminaries must be reviewed and understood before memorizing the new reporting nomenclature and mechanics:

PRELIMINARIES: 1. Definitions: A specimen isDILUTE if the creatinine is < 20mg/dL AND Sp. Gr. < 1.003

SUBSTITUTED if the creatinine is </= 5 mg/dL AND Sp.Gr. </= 1.001 OR >/= 1.020

ADULTERATED if nitrite < 500 micrograms/mL

ADULTERATED if pH is </=3 OR >/= 11

2. Reporting MechanicsAs always, reports submitted via the CCF will use the mechanics (in steps 7 and 8) of check-box options and a remarks field. As will be seen below, the new guidance calls for somewhat new nomenclature, and a more thoroughly and completely defined set of options for reporting.3. Reporting OptionsAlthough the new 1998 guidelines define the reporting process by reference to the check box options and remarkes field of the CCF, the rules do allow for other methods of reporting, including “proprietary layouts” or letters. It seems self-evident to say that reports which do not utilize the actual CCF must, nevertheless, contain all the information defined in the guidelines.

RE-TEST REPORTS FROM LAB TO MRO

~Under Construction~

REPORTS FROM THE LAB TO THE MRO MUST INCLUDE:

    1. That the controlled substances test being reported was in accordance with 49-CFR-part 40
    2. The name of the laboratory performing the test
    3. The accession number (or specimen ID number)
    4. The SSN or other unique valid ID number for the donor.

[Remember that the lab is “blind” to donor ID]

  1. The type of test indicated on the custody and control form (i.e. random, post-accident, etc.)
  2. The date and location of the test collection.
  3. The date on which the tests were performed.
  4. The identities of the persons or entities performing the collection, analysis of the specimens and serving as the MRO for the specific test.
  5. The results of each controlled substances test.
  6. The confirmed results of each positive test – and the identification of those illegal substances for which the test is positive…. wherein the term “confirmed” indicates that the laboratory has confirmed the positive test using GC/MS studies…
  7. If any QUANTITATIVE RESULTS are given in the laboratory report, employer is not authorized to receive such quantitative results and they should NOT BE TRANSMITTED BY THE MRO TO THE EMPLOYER. (Except in the case of contested results or litigation etc.)

FOR SPLIT (“BOTTLE B”) SPECIMENS

Note that “Laboratory B” is expected to carry out “Validity Studies” on a “Bottle B Referral”

just as they would on a primary specimen.

NOTE NEW LAYOUT OF STEP 7 OF COPY 3 OF CCF.

Copy 3, is the copy designated for reporting BOTTLE B, the “split specimen.”

The lab reports the results to the MRO using “Step 7” of Copy 3 of the Chain of Custody form. Chain of custody forms will be printed so as to show the following “checkbox” options in Step 7 of Copy 3… as well as a remarks field. If results are displayed or transmitted by means other than the CCF, all of the reporting data must be displayed.

Result Check Boxes will be: Reconfirmed, Failed to reconfirm, and Test not performed

Drug(s) or Metabolite(s) Checkboxes are: Amphetamines, Amphetamine, Methamphetamine,

Cocaine, Marijuana, Opiates, Codeine, Morphine, and PCP

NOMENCLATURE AND MECHANICS OF REPORTING

FOR SPLIT SPECIMEN (“BOTTLE B”)

Using the check boxes and “Remarks” blank in Step 7 copy 3 of the CCF, the lab will forward test results to the MRO as one of the following options:

RESULTS CHECK BOX  DRUG CHECK BOX REMARKS FIELD:
1. Reconfirmed Name of Drug(s)
2. Failed to reconfirm Name of Drug(s) Drug/metabolite not detected
3. Failed to reconfirm Name of Drug(s) Specimen Adulterated:
Nitrite > 500 micrograms/ml
4. Failed to reconfirm Name of Drug(s) Specimen Adulterated:
pH out of range
5. Failed to reconfirm Name of Drug(s) Specimen Adulterated:
[specify Adulterant] detected.
6. Failed to reconfirm Name of Drug(s) Specimen Substituted: Not consistent with normal human urine
7. Test Not Performed Fatal Flaw (with flaw stated)
8. Test Not Performed Uncorrected Flaw (withflaw stated)
9. Test Not Performed Specimen Unsuitable: Cannot obtain valid confirmatory test result
10. Test Not Performed Insufficient specimen volume

MRO DOES REVIEW AND VERIFICATION OF LAB RESULTS

Click here to review the VERIFICATION process.

[This is strictly an MRO function and requires “mastery” of this section]

Following the MRO’s review and Verification of the test results, come the…

REPORTS FROM MRO TO EMPLOYER

~Under Construction~

LAB REPORTS FROM MRO TO EMPLOYER MUST INCLUDE:

  1. That the controlled substances test being reported was in accordance with 49-CFR-part 40
  2. The name of the individual for whom the test results are being reported.
  3. The type of test indicated on the custody and control form (i.e. random, post-accident, etc.)
  4. The date and location of the test collection.
  5. The identities of the persons or entities performing the collection, analysis of the specimen and serving as the MRO for the specific test.
  6. Itemization of the tests performed; even if all negative.
  7. The confirmed and verified results of each positive test – and the identification of those illegal substances for which the test is positive…. wherein the term “confirmed” indicates that the laboratory has confirmed the positive test using GC/MS studies… and wherein the term “verified” means that the MRO has verified that the test truly indicates unauthorized use of the substances, using procedures defined in 49-CFR- part 40.
  8. If any QUANTITATIVE RESULTS are given in the laboratory report, employer is not authorized to receive such quantitative results and they should NOT BE TRANSMITTED BY THE MRO TO THE EMPLOYER! (Except in the case of contested results or litigation etc.)

REPORTING OF RESULTS BY MRO TO EMPLOYER
FOR SPLIT (“BOTTLE B”) SPECIMENS Note that “Laboratory B” is expected to carry out “Validity Studies” on a “Bottle B Referral” just as they would on a primary specimen. NOTE NEW LAYOUT OF STEP 7 OF COPY 3 OF CCF. Copy 3, is the copy designated for reporting BOTTLE B, the “split specimen.” The MRO reports the results to the Employer using “Step 8” of Copy 3 of the Chain of Custody form. Chain of custody forms will be printed so as to show the following “check box” options in Step 8 of Copy 3… as well as a remarks field. If results are displayed or transmitted by means other than the CCF, all of the reporting data must be displayed.

Result Check Boxes will be: Reconfirmed, Failed to reconfirm – Both Tests Canceled, and Test not performed – Both tests canceled.

Drug(s) or Metabolite(s) Checkboxes are: Amphetamines, Cocaine, Marijuana, Opiates and PCP

NOMENCLATURE AND MECHANICS OF REPORTING

FOR SPLIT SPECIMEN (“BOTTLE B”)

Using the check boxes and “Remarks” blank in Step 8 copy 3 of the CCF, the MRO will forward test results to the Employer as one of the following options:

RESULTS CHECK BOX  DRUG CHECK BOX REMARKS FIELD:
1. Reconfirmed Name of Drug
2. Failed to Reconfirm
Both Tests Canceled *
Name of Drug Drug/metabolite not detected
3. Failed to Reconfirm
“Both Tests Canceled” is lined out!
Name of Drug Specimen Adulterated: Refusal to test**
4. Failed to Reconfirm
“Both Tests Canceled” is lined out!
Name of Drug Specimen Substituted: Refusal to test**
5. Test Not Performed
Both Tests Canceled ***
Explain why test could not be performed.***

* Using the “Split Specimen Cancelation report” the MRO shall inform the Office of Drug and Alcohol Compliance of the failure to reconfirm.

** “Refusal to test” becomes the “final single result” for both primary and split specimen testing.

*** MRO orders immediate collection of another specimen [without advance warning] Also, using the “Split Specimen Cancelation Report, the MRO shall inform the Office of Drug and Alcohol Compliance of the test not performed.