Subpart G - Medical Review Officers and the Verification Process
§ 40.129 What are the MRO's functions in reviewing laboratory confirmed non-negative drug test results?
(a) As the MRO, you must do the following with respect to confirmed positive, adulterated, substituted, or invalid results you receive from a laboratory, before you verify the result and release it to the DER:
(1) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to cancel the test (see §§40.199
). Staff under your direct, personal supervision may conduct this administrative review for you, but only you may verify or cancel a test.
(2) Review Copy 1 of the CCF and ensure that it is consistent with the information contained on Copy 2, that the test result is legible, and that the certifying scientist signed the form. You are not required to review any other documentation generated by the laboratory during their analysis or handling of the specimen (e.g., the laboratory internal chain of custody).
(3) If the copy of the documentation provided to you by the collector or laboratory appears unclear, you must request that the collector or laboratory send you a legible copy.
(4) Except in the circumstances spelled out in §40.133
, conduct a verification interview. This interview must include direct contact in person or by telephone between you and the employee. You may initiate the verification process based on the laboratory results report.
(i) Negative; or
(ii) Cancelled; or
(iii) Positive, and/or refusal to test because of adulteration or substitution.
(b) Before you report a verified negative, positive, refusal to test because of adulteration or substitution, you must have in your possession the following documents:
(1) Copy 2 of the CCF, a legible copy of it, or any other CCF copy containing the employee's signature; and
(2) A legible copy (fax, photocopy, image) of Copy 1 of the CCF, containing the certifying scientist's signature.
(c) With respect to verified positive test results, place a checkmark in the “Positive” box in Step 6 on Copy 2 of the CCF, indicate the drug(s)/metabolite(s) verified positive, and sign and date the verification statement.
(d) If you cancel a laboratory confirmed positive, adulterated, substituted, or invalid result, check the “test cancelled” box (Step 6) on Copy 2 of the CCF, make appropriate annotation in the “Remarks” line, sign, provide your name, and date the verification statement.
(e) Report the result in a confidential manner (see §§40.163
(f) With respect to adulteration or substitution test results, check the “refusal to test because:” box (Step 6) on Copy 2 of the CCF, check the “Adulterated” or “Substituted” box, as appropriate, make appropriate annotation in the “Remarks” line, sign and date the verification statement.
(g) As the MRO, your actions concerning reporting confirmed positive, adulterated, or substituted results to the employer before you have completed the verification process are also governed by the stand-down provisions of §40.21
(1) If an employer has a stand-down policy that meets the requirements of §40.21
, you may report to the DER that you have received an employee's laboratory confirmed positive, adulterated, or substituted test result, consistent with the terms of the waiver the employer received. You must not provide any further details about the test result (e.g., the name of the drug involved).
(2) If the employer does not have a stand-down policy that meets the requirements of §40.21
, you must not inform the employer that you have received an employee's laboratory confirmed positive, adulterated, or substituted test result until you verify the test result. For example, as an MRO employed directly by a company, you must not tell anyone on the company's staff or management that you have received an employee's laboratory confirmed test result.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41952, Aug. 9, 2001; 73 FR 35971, June 25, 2008; 75 FR 59107, September 27, 2010; 88 FR 27645, May 2, 2023]