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Happy 4th of July!

RECEIVING OR “IMPORTING” LAB RESULTS

* not updated past the 2001 rules changes *

CONTEXT

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 positivesREPORT lab reports to employers (as defined by rules and regulations
THIS SECTION DEALS WITH THE “RECEIVING” FUNCTION

THE CARDINAL RULE OF REPORTING:

[often “broken” by DFW professionals to “speed up” service to customers]

    • In D.O.T. regulated testing, ONLY THE MRO may receive lab reports from the lab!
    • This rule applies even when the MRO is an employee of a TPA!

 

 

Question: Can a Consortium/T.P.A., employer, or other agency receive & review lab results and forward positive results for action by the MRO?
Answer: No!   Only the MRO can receive UNREVIEWED lab results! 
The MRO may, however, delegate certain review functions to a staff which s/he (the MRO) personally trains and supervises. 
[See MRO Update of Oct. 1995 – Also July 25, 1995 DOT document re. C/TPA’s]

Click here to review the DOT guidance for C/TPA’s

BACKGROUND:

NEW 1998 REPORTING RULESIn September 1998, HHS issued PD #035which 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:

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 >/= 112. 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 remarks 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.

TIME SEQUENCE OF REPORTING

NARRATIVE:
Because the reporting sequence is totally different (and somewhat illogical) when compared to the standard sequence used in clinical practice, MRO’s MUST MASTER THIS SEQUENCE in order to function without misunderstandings.  As you will see as you study the sequence it involves a complete “unlearning” of the standard “clinical” paradigm and its (logical) assumptions and a shift to a new paradigm: THE STANDARD “CLINICAL” PARADIGM & SEQUENCE:

      1. Lab performs quantitative test result.
      2. Lab immediately releases quantitative results to physician.
      3. Physician has all the information he needs to interpret lab results.
      4. Physician can make immediate clinical decisions based on lab results.

THE DRUG-TESTING PARADIGM & SEQUENCE: [Dividing into “phases” will help clarify this] Phase One:

        • Laboratory does “integrity screen” which includes:

Creatinine, pH, Nitrites, and (if Creatinine >20) Specific Gravity.

        • Lab reports “substituted” and “adulterated” specimens to MRO.
        • Remainder of specimens (including “dilutes”) forwarded for I/A screen.

Phase Two:

        • Laboratory does QUANTITATIVE Immuno Assay screen on specimen.
        • Laboratory releases negative results as QUALITATIVEresults.

[Negative means only that results were below cut-off]

        • Laboratory not permitted to release unconfirmed Immuno Assay results on non negatives:
        • Laboratory forwards non-negatives for gc/ms confirmation.

Phase Three:

        • Laboratory does gc/ms confirmation studies.
        • If Negative, the result of “negative” is reported to MRO.
        • For opiates over 2,000, Lab automatically does 6-AM assay. (also gc/ms)

If 6-AM is “positive” [above cut-off of 10ng.mL] lab reports “positive 6-AM.”

        • For all other “positives,” the lab now reports the Qualitative I/A results.

[ “Positive” report means the I/A results are now confirmed and are being reported.]

        • Lab does NOT release the actual gc/ms results.

Phase Four:      If the issue of substance abuse is still unresolved despite labs and donor interview:MRO orders “verification” studies which are:

          • Quantitative results (These are already available at lab but not released.)
          • Methamphetamine isomers. (if needed to resolve an “Amphetamine Positive”)
          • 6-AM (if not done automatically and heroin abuse is suspected.)

Lab reports these results (all quantitative) to MRO GRAPHIC OUTLINE OF REPORTING SEQUENCE:

 

ASSAY PERFORMED LAB ACTION MRO RECEIVES: MRO REQUESTS:
PHASE 1 “Integrity Tests”
                INTEGRITY O.K. pH, Nitrite, Creatine, Sp.Gr. Forwarded for I/A Screening NOTHING!
                 ADULTERATED Report to MRO: Adulterated/R.T.T. Adulterated: Refusal to Test
                  SUBSTITUTED Report to MRO: Substituted/R.T.T. Substituted: Refusal to Test
PHASE 2  “I/A Screening”
                        NEGATIVE Quantitative I/A Screen Qual. result (“neg”) to MRO Qual. “Negative” I/A results
               NON-NEGATIVE Forwarded for gc/ms confirmation NOTHING!
PHASE 3   “gc/ms conf’n”
                        NEGATIVE Quant. GC/MSconfirmation “Negative” I/Areported to MRO “Negative” (unconfirmed) I/A
             OPIATE >2000 Automatic 6-AM assay Lab forwards Pos. 6-AM to MRO “Positive” 6-AM
    ALL OTHER POSITIVES Quant. GC/MSconfirmation “Positive” I/Areported to MRO “Positive” I/Aresults
PHASE 4:  “Verification”
                         “QUANTS” NONE: (Results on file at lab) Quant. GC/MSresults to MRO Quant.GC/MSresults Quantitative Results
        METHAMP’ ISOMERS Methamphetamine Isomers Isomer results sent to MRO Methamph’ Isomer Results Methamphet’ Isomers
                               6-AM  GC/MS assay for 6-AM 6-AM results sent to MRO 6-AM Results 6-AM Results

 

CONTENT OF REPORTS

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 “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.)

 

MECHANICS OF REPORTS ~~ LAB TO MRO

NOTE THE LAYOUT OF STEP 7 OF COPY 2 OF CCF.

Copy 2, is the copy designated for reporting BOTTLE A, the primary specimen.
The lab reports the results to the MRO using “Step 7” of Copy 2 of the Chain of Custody form. All chain of custody forms will be printed so as to show the following “check box” options in Step 7 of Copy 2… 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 are: Negative, Positive, and Test Not Performed.
Drug(s) or Metabolite(s) Check boxes are: Amphetamines, Amphetamine, Methamphetamine, Morphine Cocaine, Marijuana, Opiates, Codeine, Morphine, and PCPNEW NOMENCLATURE AND MECHANICS OF REPORTING  [FOR PRIMARY SPECIMEN (“BOTTLE A”)]Using the check boxes and “Remarks” blank in Step 7 copy 2 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. Negative
2. Negative Dilute
3. Positive Name of Drug(s)
4. Positive Name of Drug(s) Dilute
5. Test Not Performed Fatal Flaw
(with the flaw stated)
6. Test Not Performed Uncorrected Flaw
(with flaw stated)
7. Test Not Performed Specimen Unsuitable:
Cannot obtain valid drug test
8. Test Not Performed Specimen Adulterated:
Nitrite > 500 micrograms/ml
9. Test Not Performed Specimen Adulterated:
pH out of range.
10. Test Not Performed Specimen Adulterated:
[specify Adulterant] detected.
11. Test Not Performed Specimen Substituted:
Not consistent with human urine.

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

    1. “Quants” for validity tests will not be routinely reported, but may be forwarded to MRO upon request.
    2. The donor no longer has the right to a Split Specimen (Bottle B) retest!
    3. The lab shall NOT report the test as “negative”
    4. 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.)
    5. 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!
    6. There is NO REQUIREMENT for the MRO to interview these donors…however,
      • Some employers are now “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 should be an assertion to that effect in the report to the employer:

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.” FOR SPLIT (“BOTTLE B”) SPECIMENS:The reporting of “Bottle B” re-tests will be much less frequent than “standard” (bottle A) reports, consequently, it is not as critical for the MRO to memorize.  Therefore, a special “section” has been created for the importing and reporting of “Bottle B” re-test results.
To review or import the section on “Bottle B” reporting, ‘

Click here or navigate to Bottle-B or Retesting