§ 40.187 What does the MRO do with split specimen laboratory results?

As anthe MRO, the split specimen laboratory results you receive will fall into five categories. You must take the following actionsaction, as appropriate, when a laboratory reports thesplit followingspecimen results ofto split specimen tests:you.
(a) Reconfirmed.Category (1): InThe thelaboratory casereconfirmed ofone aor reconfirmedmore positiveof testthe forprimary aspecimen drugresults. orAs drugthe metaboliteMRO, reportyou themust reconfirmationreport to the DER and the employee the result(s) that was/were reconfirmed.
(21) In the case of a reconfirmed adulteratedpositive ortest(s) substitutedfor result,drug(s) reportor todrug themetabolite(s), DER and the employeepositive thatis the specimenfinal wasresult.
(2) adulteratedIn orthe substituted,case either of which constitutes a refusalreconfirmed toadulterated test.or Thereforesubstituted result, “the refusal to test” is the final result.
(3) In the case of a reconfirmedcombination substitutedpositive result,and inrefusal whichto test results, the creatininefinal concentrationresult foris theboth primarypositive specimenand wasrefusal lessto thantest.
(b) Category 2: mg/dLThe andlaboratory thefailed creatinineto concentrationreconfirm all of the splitprimary specimen isresults betweenbecause, 2as andappropriate, 5 mgdrug(s)/DL,drug inclusive,metabolite(s) reportwere thenot resultdetected; toadulteration thecriteria employerwere asnot “dilute”met; and/or instructsubstitution thecriteria employerwere tonot conduct an immediate recollection under direct observationmet.
(b) FailedAs tothe Reconfirm:MRO, Drug(s)/Drugyou Metabolite(s)must Notreport Detected. (1) Report to the DER and the employee that boththe teststest must be cancelled.
(21) UsingAs the MRO, you must inform ODAPC of the failure to reconfirm using the format in Appendix D to this part,.
(2) informIn ODAPCa ofcase where the failuresplit failed to reconfirm.
(c) Failedbecause tothe Reconfirm:substitution Adulterationcriteria orwere Substitutionnot (asmet appropriate)and Criteriathe Notsplit Met.specimen (1)creatinine Reportconcentration was equal to theor DERgreater andthan the2mg/dL employeebut thatless boththan testsor mustequal beto cancelled.
(2)5mg/dL, Usingas the formatMRO, inyou Appendixmust, Din addition to step (b)(1) of this partparagraph, informdirect ODAPCthe ofDER to ensure the failureimmediate tocollection reconfirm.
(d)of Failedanother tospecimen Reconfirm:from Specimenthe notemployee Availableunder fordirect Testing.observation, (1)with Reportno notice given to the DERemployee andof this collection requirement until immediately before the employeecollection.
(3) thatIn botha testscase mustwhere bethe cancelledsplit failed to reconfirm and the reasonprimary forspecimen's cancellation.
(2)result Directwas also invalid, direct the DER to ensure the immediate collection of another specimen from the employee under direct observation, with no notice given to the employee of this collection requirement until immediately before the collection.
(3c) UsingCategory the3: formatThe inlaboratory Appendixfailed D to thisreconfirm partall of the primary specimen results, notifyand ODAPCalso ofreported that the failuresplit tospecimen reconfirmwas invalid, adulterated, and/or substituted.
(e1) FailedIn the case where the laboratory failed to Reconfirm:reconfirm Specimenall Resultsof Invalid.the primary specimen results and the split was reported as invalid, as the MRO, you must:
(1i) Report to the DER and the employee that boththe teststest must be cancelled and the reason for the cancellation.
(2ii) Direct the DER to ensure the immediate collection of another specimen from the employee under direct observation, with no notice given to the employee of this collection requirement until immediately before the collection.
(3iii) UsingInform ODAPC of the failure to reconfirm using the format in Appendix D to this part,.
(2) notifyIn ODAPCthe ofcase where the failurelaboratory failed to reconfirm.
(f) Failedany toof Reconfirm:the Splitprimary Specimenspecimen Adulterated.results, and the split was reported as adulterated and/or substituted, as the MRO, you must:
(1i) Contact the employee and inform the employee that the laboratory has determined that his or her split specimen is adulterated and/or substituted, as appropriate.
(2ii) Follow the procedures of § 40.145 to determine if there is a legitimate medical explanation for the laboratory finding of adulteration and/or substitution, as appropriate.
(3iii) If you determine that there is a legitimate medical explanation for the adulterated and/or substituted test result, report to the DER and the employee that the test ismust be cancelled.; Usingand inform ODAPC of the failure to reconfirm using the format in Appendix D to this part, notify ODAPC of the result.
(4iv) If you determine that there is not a legitimate medical explanation for the adulterated and/or substituted test result, you must take the following steps:
(iA) Report the test to the DER and the employee as a verified refusal to test. Inform the employee that he or she has 72 hours to request a test of the primary specimen to determine if the adulterant found in the split specimen also is also present in the primary specimen and/or to determine if the primary specimen meets appropriate substitution criteria.
(iiB) Except thatwhen the request is for a test of the primary specimen and is being made to the laboratory that tested the primary specimen, follow the procedures of §§ 40.153, 40.171, 40.173, 40.179, 40.181, and 40.185, as appropriate.
(iiiC) As the laboratory that tests the primary specimen to reconfirm the presence of the adulterant found in the split specimen and/or to determine that the primary specimen meets appropriate substitution criteria, report your result to the MRO on a photocopy (faxed, mailed, scanned, couriered) of Copy 1 of the CCF .
(ivD) If the test of the primary specimen reconfirms the adulteration and/or substitution finding of the split specimen, as the MRO you must report the test result as a refusal to test as provided in §paragraph 40.187(a)(2) of this section.
(vE) If the test of the primary specimen fails to reconfirm the adulteration and/or substitution finding of the split specimen, as the MRO you must cancel the test, following procedures in paragraph (b) of this section.
(d) FollowCategory 4: The laboratory failed to reconfirm one or more but not all of the proceduresprimary specimen results, and also reported that the split specimen was invalid, adulterated, and/or substituted. As the MRO, in the case where the laboratory reconfirmed one or more of the primary specimen result(s), you must follow procedures in paragraph (ea) of this section and:
(1) Report that the split was also reported as being invalid, adulterated, and/or substituted (as appropriate).
(2) Inform the DER to take action only on the reconfirmed result(s).
(e) Category 5: The split specimen was not available for testing or there was no split laboratory available to test the specimen. As the MRO, you must:
(1) Report to the DER and the employee that the test must be cancelled and the reason for the cancellation;
(2) Direct the DER to ensure the immediate recollection of another specimen from the employee under direct observation, with no notice given to the employee of this collection requirement until immediately before the collection; and
(3) Notify ODAPC of the failure to reconfirm using the format in Appendix D to this situationpart.
(gf) For all split specimen results, as the MRO you must:
(1) Enter your name, sign, and date (Step 7) of Copy 2 of the CCF.
(h2) Send a legible copy of Copy 2 of the CCF (or a signed and dated letter, see § 40.163 ) to the employer and keep a copy for your records. Transmit the document as provided in § 40.167.
[6573 FR 7952635973, Dec.June 1925, 2000, as amended at 66 FR 41953, Aug. 9, 2001; 68 FR 31626, May 28, 20032008]