Important information regarding reporting results to employers
 
Important information regarding reporting results to employers
  REPORTING RESULTS TO EMPLOYERS

* 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 positives
            REPORT lab reports to employers (as defined by rules and regulations
             
          THIS SECTION DEALS WITH THE "REPORTING" FUNCTION
 
BACKGROUND:
 
     NEW 1998 REPORTING RULES
      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:
1. Definitions: A specimen is DILUTE 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 Mechanics As 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 Options Although 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. 
CONTENT OF REPORTS
 
    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. The verified results of each controlled substances test, either positive or negative, and if positive, the identity of the controlled substance(s) for which the test was verified positive....[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.]
    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.)
 
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!
MECHANICS OF MRO's REPORT TO THE EMPLOYER
 
    GENERAL RULE:
    • Reporting mechanics and requirements are fairly uniform in all Federally regulated programs... but
    • In "unregulated" testing, requirements can vary considerably.
    • It's important to understand what rules govern each employer and abide by them.
    REGULATIONS:
      §382.407  Medical review officer notifications to the employer
      (a) The medical review officer may report to the employer using any [confidential] communictions device, but in all instances a signed, written notification must be forwarded within three business days of completion of the medical review officer's review.
    GUIDANCE:  (Federal Guidance is regulatory "interpretation" and has the same imperative as a "regulation.")
    • The initial report to an employer may be by telephone.
    • All reports, and their transmissions and storage means, must be strictly confidential!
    • In every case, a signed written report must be forwarded within 3 business days of completing review.
    • Electronic Signatures are specifically not approved by DOT.
    NOTE  LAYOUT OF STEP 8 OF COPIES 2 & 4 OF THE CCF.
    • Copy 2, is the HHS designated copy for the lab to report the results of bottle A (the primary specimen) to the MRO.
    • DOT forbids use of copy 2 for MRO reports to employer... and specifically allows use of Copy 4 (the MRO copy) for this purpose.   (** See exact DOT guidance on PD #035 below)
    • The MRO reports to the Employer using "Step 8" of Copy 2/4 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 8 ... 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: Negative, Positive, Test Not Performed, and Test Canceled
    • Drug(s) or Metabolite(s) Check boxes are:    Amphetamines, Cocaine, Marijuana, Opiates and PCP
     
    NEW NOMENCLATURE AND MECHANICS OF REPORTING

    FOR PRIMARY SPECIMEN ("BOTTLE A")

    ** The actual language of the DOT guidance on PD #035 is as follows:

      " The Federal CCF requires the MRO to report drug test results as either Negative, Positive, Test Not Performed, or Test Canceled.  The MRO must also include an appropriate comment on the "Remarks" line in Step 8 on Copy 2 (required by HHS) or Copoy 4 (permissible for DOT) of the CCF when additional information is reported by the laboratory.  Note:  Under no circumstances should Copy 2 of the CCF be sent to the employer to report results.  The MRO may use a photocopy of Copy 4 of the CCF (assuming that the information on Copy 4 is legible), a memorandum, or a letter format to report a result to the employer."  [Italics by DOT]
       
     
    WEBMASTER'S NOTE: 
     
    Although it is important to memorize the "display" of results-reporting options below and to adhere to them in reporting results to employers,  we have found in our MRO organization that an alternative "list" of options is much easier to learn and teach, especially when trying to explain the new regulations to employers.  (A duty which has not yet been taken on by any federal agency.) 

    In addition, the following "alternative" list of "final results options" is far easier to apply in a flow chart or cybernetic program.  

    Our "display" of (seven) final outcomes is as follows:  Negative, Positive, Non-contact Positive, Canceled, Unsuitable, Adulterated, and Sustituted.  The required modifying information and assertions must, of course be appended to these basic results in the final report. 

    In the table below, our "list" is shown in bold red text.  It is the basis for the system of "Final results" options used in the "Verification" section of this website. The "Non-contact Positive" was not mentioned in PD #035. 

     
    Using the check boxes and "Remarks" blank in Step 8 of the CCF, the MRO will forward test results to the Employeras 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. Test Not Performed  
AND Test Canceled		   Fatal Flaw (with flaw stated)
5. Test Not Performed  
AND Test Canceled		   Uncorrected Flaw (with flaw stated).
6. Test Not Performed  
AND Test Canceled **		   Specimen Unsuitable:  
Cannot obtain valid drug test result. **
7. Test Not Performed  
AND Test Canceled***		   Specimen Unsuitable:   
Cannot obtain valid drug test result. NEW WITNESSED COLLECTION REQUIRED ***
8. Test Not Performed   Specimen Adulterated:   
Refusal to test!  ****
9. Test Not Performed   Specimen Substituted:   
Refusal to test! ****
  * A dilute negative is VALID and becomes part of the donor's record. The employer is given the OPTION of requiring a witnessed   collection the NEXT TIME the donor comes due.

** This result is called an "explained unsuitable." No action is required!

*** This result is an "unexplained unsuitable." REQUIRES NEW WITNESSED COLLECTION.

**** REMINDER: 

    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 -- nor any 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. 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,