What does the MRO do with split specimen laboratory results?

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

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.

(3) In the case of a reconfirmed substituted result, in which the creatinine concentration for the primary specimen was less than 2 mg/dL and the creatinine concentration of the split specimen is between 2 and 5 mg/DL, inclusive, report the result to the employer as “dilute” and instruct the employer to conduct an immediate recollection under direct observation.

(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.

[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41953, Aug. 9, 2001; 68 FR 31626, May 28, 2003]