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Drug Testing Laws

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Subpart H - Split Specimen Tests

§40.171 How does an employee request a test of a split specimen?
(a) As an employee, when the MRO has notified you that you have a verified positive drug test or refusal to test because of adulteration or substitution, you have 72 hours from the time of notification to request a test of the split specimen. The request may be verbal or in writing. If you make this request to the MRO within 72 hours, you trigger the requirements of this section for a test of the split specimen.
(b)(1) If, as an employee, you have not requested a test of the split specimen within 72 hours, you may present to the MRO information documenting that serious injury, illness, lack of actual notice of the verified test result, inability to contact the MRO (e.g., there was no one in the MRO's office and the answering machine was not working), or other circumstances unavoidably prevented you from making a timely request.
(2) As the MRO, if you conclude from the employee's information that there was a legitimate reason for the employee's failure to contact you within 72 hours, you must direct that the test of the split specimen take place, just as you would when there is a timely request.
(c) When the employee makes a timely request for a test of the split specimen under paragraphs (a) and (b) of this section, you must, as the MRO, immediately provide written notice to the laboratory that tested the primary specimen, directing the laboratory to forward the split specimen to a second HHS-certified laboratory. You must also document the date and time of the employee's request.

§40.173 Who is responsible for paying for the test of a split specimen?
(a) As the employer, you are responsible for making sure (e.g., by establishing appropriate accounts with laboratories for testing split specimens) that the MRO, first laboratory, and second laboratory perform the functions noted in §§40.175 - 40.185 in a timely manner, once the employee has made a timely request for a test of the split specimen.
(b) As the employer, you must not condition your compliance with these requirements on the employee's direct payment to the MRO or laboratory or the employee's agreement to reimburse you for the costs of testing. For example, if you ask the employee to pay for some or all of the cost of testing the split specimen, and the employee is unwilling or unable to do so, you must ensure that the test takes place in a timely manner, even though this means that you pay for it.
(c) As the employer, you may seek payment or reimbursement of all or part of the cost of the split specimen from the employee (e.g., through your written company policy or a collective bargaining agreement). This part takes no position on who ultimately pays the cost of the test, so long as the employer ensures that the testing is conducted as required and the results released appropriately.

§40.175 What steps does the first laboratory take with a split specimen?
(a) As the laboratory at which the primary and split specimen first arrive, you must check to see whether the split specimen is available for testing.
(b) If the split specimen is unavailable or appears insufficient, you must then do the following:
(1) Continue the testing process for the primary specimen as you would normally. Report the results for the primary specimen without providing the MRO information regarding the unavailable split specimen.
(2) Upon receiving a letter from the MRO instructing you to forward the split specimen to another laboratory for testing, report to the MRO that the split specimen is unavailable for testing. Provide as much information as you can about the cause of the unavailability.
(c) As the laboratory that tested the primary specimen, you are not authorized to open the split specimen under any circumstances (except when the split specimen is redesignated as provided in §40.83 ).
(d) When you receive written notice from the instructing you to send the split specimen to another HHS-certified laboratory, you must forward the following items to the second laboratory:
(1) The split specimen in its original specimen bottle, with the seal intact;
(2) A copy of the MRO's written request; and
(3) A copy of Copy 1 of the CCF, which identifies the drug(s)/metabolite(s) or the validity criteria to be tested for.
(e) You must not send to the second laboratory any information about the identity of the employee. Inadvertent disclosure does not, however, cause a fatal flaw.
(f) This subpart does not prescribe who gets to decide which HHS-certified laboratory is used to test the split specimen. That decision is left to the parties involved.

§40.177 What does the second laboratory do with the split specimen when it is tested to reconfirm the presence of a drug or drug metabolite?
(a) As the laboratory testing the split specimen, you must test the split specimen for the drug(s)/drug metabolite(s) detected in the primary specimen.
(b) You must conduct this test without regard to the cutoff concentrations of §40.87 .
(c) If the test fails to reconfirm the presence of the drug(s)/drug metabolite(s) that were reported positive in the primary specimen, you must conduct validity tests in an attempt to determine the reason for being unable to reconfirm the presence of the drug(s)/metabolite(s). You should conduct the same validity tests as you would conduct on a primary specimen set forth in §40.91 .
(d) In addition, if the test fails to reconfirm the presence of the drugs/drugs metabolites or validity criteria that were reported in the primary specimen, you may transmit the specimen or an aliquot of it to another HHS-certified laboratory that will conduct another reconfirmation test.

§40.179 What does the second laboratory do with the split specimen when it is tested to reconfirm an adulterated test result?
As the laboratory testing the split specimen, you must test the split specimen for the adulterant detected in the primary specimen, using the criteria of §40.95 just as you would do for a primary specimen. The result of the primary specimen is reconfirmed if the split specimen meets these criteria.

§40.181 What does the second laboratory do with the split specimen when it is tested to reconfirm a substituted test result?
As the laboratory testing the split specimen, you must test the split specimen using the criteria of §40.93(b) , just as you would do for a primary specimen. The result of the primary specimen is reconfirmed if the split specimen meets these criteria.

§40.183 What information do laboratories report to MROs regarding split specimen results?
(a) As the laboratory responsible for testing the split specimen, you must report split specimen test results by checking the “Reconfirmed” box or the “Failed to Reconfirm” box (Step 5(b)) on Copy 1 of the CCF.
(b) If you check the “Failed to Reconfirm” box, one of the following statements must be included (as appropriate) on the “Reason” line (Step 5(b)):
(1) “Drug(s)/Drug Metabolite(s) Not Detected.”
(2) “Adulterant not found within criteria.”
(3) "Specimen not consistent with substitution criteria [specify creatinine, specific gravity, or both]”
(4) “Specimen not available for testing.”
(c) As the laboratory certifying scientist, enter your name, sign, and date the CCF.

§40.185 Through what methods and to whom must a laboratory report split specimen results?
(a) As the laboratory testing the split specimen, you must report laboratory results directly, and only, to the MRO at his or her place of business. You must not report results to or through the DER or another service agent (e.g., a C/TPA).
(b) You must fax, courier, mail, or electronically transmit a legible image or copy of the fully-completed Copy 1 of the CCF, which has been signed by the certifying scientist.
(c) You must transmit the laboratory result to the MRO immediately, preferably on the same day or next business day as the result is signed and released.

§40.187 What does the MRO do with split specimen laboratory results?
As an MRO, you must take the following actions when a laboratory reports the following results of split specimen tests:
(a) Reconfirmed. (1) In the case of a reconfirmed positive test for a drug or drug metabolite, report the reconfirmation to the DER and the employee.
(2) In the case of a reconfirmed adulterated or substituted result, report to the DER and the employee that the specimen was adulterated or substituted, either of which constitutes a refusal to test. Therefore, “refusal to test” is the final result.
(b) Failed to Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected. (1) Report to the DER and the employee that both tests must be cancelled.
(2) Using the format in Appendix D to this part, inform ODAPC of the failure to reconfirm.
(c) Failed to Reconfirm: Adulteration or Substitution (as appropriate) Criteria Not Met. (1) Report to the DER and the employee that both tests must be cancelled.
(2) Using the format in Appendix D to this part, inform ODAPC of the failure to reconfirm.
(d) Failed to Reconfirm: Specimen not Available for Testing. (1) Report to the DER and the employee that both tests must be cancelled and the reason for cancellation.
(2) 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.
(3) Using the format in Appendix D to this part, notify ODAPC of the failure to reconfirm
(e) Failed to Reconfirm: Specimen Results Invalid. (1) Report to the DER and the employee that both tests must be cancelled and the reason for cancellation.
(2) 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.
(3) Using the format in Appendix D to this part, notify ODAPC of the failure to reconfirm.
(f) Failed to Reconfirm: Split Specimen Adulterated. (1) Contact the employee and inform the employee that the laboratory has determined that his or her split specimen is adulterated.
(2) Follow the procedures of §40.145 to determine if there is a legitimate medical explanation for the laboratory finding of adulteration.
(3) If you determine that there is a legitimate medical explanation for the adulterated test result, report to the DER and the employee that the test is cancelled. Using the format in Appendix D to this part, notify ODAPC of the result.
(4) If you determine that there is not a legitimate medical explanation for the adulterated test result, take the following steps:
(i) 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 present in the primary specimen.
(ii) Except that 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, and 40.185.
(iii) As the laboratory that tests the primary specimen to reconfirm the presence of the adulterant found in the split specimen, report your result to the MRO on a photocopy (faxed, mailed, scanned, couriered) of Copy 1 of the CCF.
(iv) If the test of the primary specimen reconfirms the adulteration finding of the split specimen, as the MRO you must report the test result as a refusal as provided in §40.187(a)(2).
(v) If the test of the primary specimen fails to reconfirm the adulteration finding of the split specimen, as the MRO you cancel the test. Follow the procedures of paragraph (e) of this section in this situation.
(g) Enter your name, sign and date (Step 7) of Copy 2 of the CCF.
(h) 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.

§40.189 Where is other information concerning split specimens found in this regulation?
You can find more information concerning split specimens in several sections of this part:
§40.3 – definition.
§40.65 - quantity of split specimen.
§40.67 - directly observed test when split specimen is unavailable.
§§40.71 - 40.73 - collection process for split specimens.
§40.83 - laboratory accessioning of split specimens.
§40.99 - laboratory retention of split specimens
§40.103 - blind split specimens.
§40.153 - MRO notice to employees on tests of split specimen.
§§40.193 and 40.201 - MRO actions on insufficient or unavailable split specimens.
Appendix D to Part 40 - Report format for split specimen failure to reconfirm.

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