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Question

REGULATORY CITATIONS

CHECKLIST OF MEDICAL REVIEW ACTIVITIES

MRO QUALIFICATIONS AND AFFILIATIONS

Please describe your qualifications to serve as a MRO.

Section 40.121 states: “To be qualified to act as an MRO in the DOT drug testing program, you must meet each of the requirements of this section:

(a) Credentials. You must be a licensed physician (Doctor of Medicine or Osteopathy).

(b) Basic knowledge. You must be knowledgeable in the following areas:

(1) You must be knowledgeable about and have clinical experience in controlled substances abuse disorders, including detailed knowledge of alternative medical explanations for laboratory confirmed drug test results.

(2) You must be knowledgeable about issues relating to adulterated and substituted specimens as well as the possible medical causes of specimens having an invalid result.

(3) You must be knowledgeable about this part, the DOT MRO Guidelines, and the DOT agency regulations applicable to the employers for whom you evaluate drug test results, and you must keep current on any changes to these materials.”

Did you become a MRO before or after August 1, 2001?

If you became a MRO after August 1, 2001, do you have documentation that you have successfully completed MRO training and passed the examination required by Part 40?

Section 40.121(c)(3)(iii) states: “If you become an MRO on or after August 1, 2001, you must meet the qualification training requirement before you begin to perform MRO functions.”

Section 40.121(c)(2) states: “Following your {the MRO’s] completion of qualification training under paragraph (c)(1) of this section, you must satisfactorily complete an examination administered by a nationally-recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of DOT-mandated drug tests. The examination must comprehensively cover all the elements of qualification training listed in paragraph (c)(1) of this section.”

Section 40.121(e) states: “You [the MRO] must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.”

What is the continuing education requirement for a MRO, and what is the length of time of the cycle within which you acquire the training?

Section 40.121(d) states: “During each three-year period from the date on which you [the MRO] satisfactorily complete the examination under paragraph (c)(2) of this section, you must complete continuing education consisting of at least 12 professional development hours (e.g., Continuing Education Medical Units) relevant to performing MRO functions.”

Do you have a copy of 49 CFR Part 40 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs (published December 19, 2000 and amended August 9, 2001)?

Section 40.123(b)(3) states: “You [the MRO] must be knowledgeable about this part, the DOT MRO Guidelines, and the DOT agency regulations applicable to the employers for whom you evaluate drug test results, and you must keep current on any changes to these materials. The DOT MRO Guidelines document is available from ODAPC (Department of Transportation, 400 7th Street, SW., Room 10403, Washington DC, 20590, 202-366-3784, or on the ODAPC web site (http://www.dot.gov/ost/dapc).”

What is your professional relationship with this transit operation?

Section 40.125 states: “As an MRO, you may not enter into any relationship with an employer’s laboratory that creates a conflict of interest or the appearance of a conflict of interest with your responsibilities to that employer. You may not derive any financial benefit by having an employer use a specific laboratory. For examples of relationships between laboratories and MROs that the Department views as creating a conflict of interest or the appearance of such a conflict, see Section 40.101(b).”

Are there any prohibitions against the MRO having a financial interest in the laboratory being utilized?

Section 40.125 states: “As an MRO, you may not enter into any relationship with an employer’s laboratory that creates a conflict of interest or the appearance of a conflict of interest with your responsibilities to that employer. You may not derive any financial benefit by having an employer use a specific laboratory. For examples of relationships between laboratories and MROs that the Department views as creating a conflict of interest or the appearance of such a conflict, see Section 40.101(b).”

Does the laboratory transmit the test results to you directly, or does the laboratory transmit reports through a C/TPA to you?

Section 40.97(b) states: “As a laboratory, 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 a service agent (e.g., C/TPA).”

Section 40.355 states: ”As a service agent, you are subject to the following limitations concerning your activities in the DOT drug and alcohol testing program.

(b) You must not act as an intermediary in the transmission of drug test results from the laboratory to the MRO. That is, the laboratory may not send results to you, with you in turn sending them to the MRO for verification. For example, a practice in which the laboratory transmits results to your computer system, and you then assign the results to a particular MRO, is not permitted.“

Do you report drug test results to the transit system through a consortium (C/TPA), or directly to the designated individual (DER)?

Section 40.345(a) states: “As a C/TPA or other service agent, you may act as an intermediary in the transmission of drug and alcohol testing information in the circumstances specified in this section only if the employer chooses to have you do so. Each employer makes the decision about whether to receive some or all of this information from you, acting as an intermediary, rather than directly from the service agent who originates the information (e.g., an MRO or BAT).”

NOW, I WOULD LIKE TO ASK A FEW QUESTIONS ABOUT YOUR GENERAL RESPONSIBILITIES.

Do you ensure that drug tests conducted under the FTA regulations by this transit system are analyzed by a laboratory on the current DHHS approved list?

Section 40.81(a) states: “As a drug-testing laboratory located in the U.S., you are permitted to participate in DOT drug testing only if HHS under the National Laboratory Certification Program (NLCP) certifies you for all testing required under this part.”

As a MRO, are you required on a quarterly basis to personally review a certain percentage of all Custody and Control Forms (CCFs) reviewed by your staff? If so, what percentage of CCFs must you review?

Section 40.127(g)(2) states: “You [the MRO] are required to personally review at least 5 percent of all CCFs reviewed by your staff on a quarterly basis, including all results that required a corrective action. However, you need not review more than 500 negative results in any quarter.”

At a minimum, what items do you check in your quarterly review of CCFs?

Section 40.127(g)(3) states: “Your [the MRO] review must, as a minimum, include the CCF, negative laboratory test result, any accompanying corrective documents, and the report sent to the employer. You must correct any errors that you discover. You must take action as necessary to ensure compliance by your staff with this part and document your corrective action. You must attest to the quality assurance review by initialing the CCFs that you review.”

Must you take any action if, in reviewing 5 percent of CCFs each quarter, you identify a test with an uncorrected non-fatal flaw or error?

Section 40.127(g)(3) states: “Your [the MRO] review must, as a minimum, include the CCF, negative laboratory test result, any accompanying corrective documents, and the report sent to the employer. You must correct any errors that you discover. You must take action as necessary to ensure compliance by your staff with this part and document your corrective action. You must attest to the quality assurance review by initialing the CCFs that you review.”

Do you report both positive and negative test results to the employer, or only positive test results?

Section 40.163(a) states: “As the MRO, it is your responsibility to report all drug test results to the employer.”

What do you report to the employer if you conclude that there is a legitimate medical explanation for a confirmed positive test result that is consistent with legal drug use?

Section 40.137(d) states: “If you determine that there is a legitimate medical explanation, you must verify the test result as negative. Otherwise, you must verify the test result as positive.”

Do you have a method for identifying yourself and confirming your identity when you need to talk with the DER?

Section 40.167(b) states: “As the MRO or C/TPA who transmits drug test results to the employer, you must comply with the following requirements:

(2) You are responsible for identifying yourself to the DER, and the DER must have a means to confirm your identification.”

When you report positive test results to the employer or C/TPA, do you report the drug (or drugs) found?

Section 40.129(c) states: “With respect to verified positive test results, place a check mark in the ``Positive'' box (Step 6) on Copy 2 of the CCF, indicate the drug(s)/metabolite(s) detected on the ``Remarks'' line, sign and date the verification statement.”

Section 40.163(c) states: “If you [the MRO] do not report test results using Copy 2 of the CCF for this purpose, you must provide a written report (e.g., a letter) for each test result. This report must, as a minimum, include the following information: . . .

(6) For verified positive tests, the drug(s)/metabolite(s) for which the test was positive . . .”

On your request, do the laboratories provide you with the quantitation of individual test results?

Section 40.97(e) states: “You [the laboratory] must provide quantitative values for confirmed positive drug, adulterated, and substituted test results to the MRO when the MRO requests you to do so in writing. The MRO's request may either be a general request covering all such results you send to the MRO or a specific case-by-case request.”

If an employer requests, do you provide the quantitative values of the drugs verified positive, or the results of validity tests?

Section 40.163(g) states: “You must not provide quantitative values to the DER or C/TPA for drug or validity test results. However, you must provide the test information in your possession to a SAP who consults with you (see Section 40.293(g)).”

If a SAP requests, are you allowed to provide any medical information or the quantitative values for drugs or validity test results?

Section 40.163(g) states: “You must not provide quantitative values to the DER or C/TPA for drug or validity test results. However, you must provide the test information in your possession to a SAP who consults with you (see Section 40.293(g)).”

I WOULD NOW LIKE TO DISCUSS THE FUNCTIONS YOU PERFORM IN YOUR REVIEW OF A CONFIRMED POSITIVE TEST RESULT

Do you (or your staff) contact the employee first to begin the verification process, or do you contact the employer first and ask the employer to contact the individual?

Section 40.131(c) states: “As the MRO, you or your staff must make reasonable efforts to reach the employee at the day and evening telephone numbers listed on the CCF. Reasonable efforts include, as a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the employee at the day and evening telephone numbers listed on the CCF. If you or your staff cannot reach the employee directly after making these efforts, you or your staff must take the following steps:

(1) Document the efforts you made to contact the employee, including dates and times. If both phone numbers are incorrect (e.g., disconnected, wrong number), you may take the actions listed in paragraph (c)(2) of this section without waiting the full 24-hour period.

(2) Contact the DER, instructing the DER to contact the employee.”

Are there requirements on the number of times you or your staff must attempt to contact the employee regarding a positive test?

Section 40.131(c) states: “As the MRO, you or your staff must make reasonable efforts to reach the employee at the day and evening telephone numbers listed on the CCF. Reasonable efforts include, as a minimum, three attempts, spaced reasonably over a 24-hour period, to reach the employee at the day and evening telephone numbers listed on the CCF. If you or your staff cannot reach the employee directly after making these efforts, you or your staff must take the following steps:

(1) Document the efforts you made to contact the employee, including dates and times. If both phone numbers are incorrect (e.g., disconnected, wrong number), you may take the actions listed in paragraph (c)(2) of this section without waiting the full 24-hour period.”

If your staff makes the initial contact for a verification interview, does your staff first inquire whether or not the individual wishes to talk with you, or does your staff always attempt to schedule an interview with you, even if the employee is reluctant to do so?

Section 40.131(b) states: “As the MRO, staff under your personal supervision may conduct this initial contact for you.

(1) This staff contact must be limited to scheduling the discussion between you and the employee and explaining the consequences of the employee’s declining to speak with you (i.e., that the MRO will verify the test without input from the employee). If the employee declines to speak with you, the staff person must document the employee’s decision, including the date and time.

(4) Since you [the MRO] are required to speak personally with the employee, face-to-face or on the phone, your staff must not inquire if the employee wishes to speak with you.”

May a staff person who is not an MRO gather and review the employee’s medical history, or must an MRO always gather and personally review the employee's medical history?

Section 40.141 states: “As the MRO, you must do the following as you make the determinations needed for a verification decision:

(a) You must conduct a medical interview. You must review the employee’s medical history and any other relevant biomedical factors presented to you by the employee. You may direct the employee to undergo further medical evaluation by you or another physician.”

Section 40.131(b)(2) states: “A staff person must not gather any medical information or information concerning possible explanations for the test result.”

Do you always conduct the verification yourself, or do others in your office who are not MROs also conduct verification interviews?

Section 40.131(b) states: “As the MRO, staff under your personal supervision may conduct this initial contact for you.

(1) This staff contact must be limited to scheduling the discussion between you and the employee and explaining the consequences of the employee’s declining to speak with you (i.e., that the MRO will verify the test without input from the employee). If the employee declines to speak with you, the staff person must document the employee’s decision, including the date and time.

(2) A staff person must not gather any medical information or information concerning possible explanations for the test result.

(3) A staff person may advise an employee to have medical information (e.g., prescriptions, information forming the basis of a legitimate medical explanation for a confirmed positive test result) ready to present at the interview with the MRO.

(4) Since you [the MRO] are required to speak personally with the employee, face-to-face or on the phone, your staff must not inquire if the employee wishes to speak with you.”

Before beginning the verification process, is there anything you are required to warn the employee concerning your obligation to disclose information to third parties?

Section 40.135(d) states: “As the MRO, you must warn an employee who has a confirmed positive, adulterated, substituted or invalid test that you are required to provide to third parties drug test result information and medical information affecting the performance of safety-sensitive duties that the employee gives you in the verification process without the employee's consent (see Section 40.327).

(1) You must give this warning to the employee before obtaining any medical information as part of the verification process.”

What elements of the CCF do you review before you make a final verification decision on a laboratory-positive test result?

Section 40.129(a) states: “As the MRO, you must --- (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 Sections 40.199 and 40.203). 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.”

To whom do you report the verified positive test result?

Section 40.165 states: “(a) As the MRO, you must report all drug test results to the DER, except in the circumstances provided for in Section 40.345.

(b) If the employer elects to receive reports of results through a C/TPA, acting as an intermediary as provided in §40.345, you must report the results through the designated C/TPA.”

How soon after verification do you transmit positive test results to the DER?

Section 40.167(b) states: “You [the MRO] must transmit to the DER on the same day the MRO verifies the result or the next business day all verified positive test results, results requiring an immediate collection under direct observation, adulterated or substituted specimen results, and other refusals to test.”

Within how many days do the regulations state that the verified test results must be received by the employer?

Section 40.167(c) states: “You [the MRO] must transmit the MRO's report(s) of verified tests to the DER so that the DER receives it within two days of verification by the MRO.”

As the MRO, can you change your initial verification of a positive drug test result or refusal to test?

Section 40.149(a) states: “As the MRO, you may change a verified positive or refusal to test drug test result only in the following situations:

(1) When you have reopened a verification that was done without an interview with an employee (see Section 40.133(c)).

(2) If you receive information, not available to you at the time of the original verification, demonstrating that the laboratory made an error in identifying (e.g., a paperwork mistake) or testing (e.g., a false positive or negative) the employee's primary or split specimen.

(3) If, within 60 days of the original verification decision:

(i) You receive information that could not reasonably have been provided to you at the time of the decision demonstrating that there is a legitimate medical explanation for the presence of drug(s)/metabolite(s) in the employee's specimen; or

(ii) You receive credible new or additional evidence that a legitimate medical explanation for an adulterated or substituted result exists.”

What is your rough estimate as to the percentage of confirmed positive test results you have verified as negative after speaking with the employee?

NOW I WOULD LIKE TO DISCUSS THE PROCEDURES YOU USE IF YOU OR YOUR STAFF ARE UNABLE TO CONTACT AN INDIVIDUAL FOR VERIFICATION OF THE TEST RESULTS

What do you do if you cannot contact the employee to conduct a verification interview?

Section 40.131(c) states: “If you or your staff cannot reach the employee directly after making these efforts, you or your staff must take the following steps:

(1) Document the efforts you made to contact the employee, including dates and times. If both phone numbers are incorrect (e.g., disconnected, wrong number), you may take the actions listed in paragraph (c)(2) of this section without waiting the full 24-hour period.

(2) Contact the DER, instructing the DER to contact the employee.

(i) You must simply direct the DER to inform the employee to contact you.

(ii) You must not inform the DER that the employee has a confirmed positive, adulterated, substituted, or invalid test result.

(iii) You must document the dates and times of your attempts to contact the DER, and you must document the name of the DER you contacted and the date and time of the contact.”

Are there circumstances under which you may verify a drug test as positive without speaking with the individual?

Section 40.133(a) states: “(1) You may verify a test result as a positive or refusal to test, as applicable, if the employee expressly declines the opportunity to discuss the test with you. You must maintain complete documentation of this occurrence, including notation of informing, or attempting to inform, the employee of the consequences of not exercising the option to speak with you.

(2) You may verify a test result as a positive or refusal to test, as applicable, if the DER has successfully made and documented a contact with the employee and instructed the employee to contact you and more than 72 hours have passed since the time the DER contacted the employee.

(3) You may verify a test result as a positive or refusal to test, as applicable, if neither you nor the DER, after making and documenting all reasonable efforts, has been able to contact the employee within ten days of the date on which the MRO receives the confirmed test result from the laboratory.”

As a MRO, can you verify a drug test result as positive if an employee expressly declines the opportunity to discuss the test with you?

Section 40.133(a)(1) states: “You [the MRO] may verify a test result as a positive or refusal to test, as applicable, if the employee expressly declines the opportunity to discuss the test with you. You must maintain complete documentation of this occurrence, including notation of informing, or attempting to inform, the employee of the consequences of not exercising the option to speak with you.”

As MRO, once the employer representative has contacted an individual directing him/her to contact you, and informed you of the contact, how many hours must you wait for the employee to contact you before you may verify a “no contact” positive?

Section 40.133(a)(2) states: “You [the MRO] may verify a test result as a positive or refusal to test, as applicable, if the DER has successfully made and documented a contact with the employee and instructed the employee to contact you and more than 72 hours have passed since the time the DER contacted the employee.”

If neither the MRO nor the designated employer representative, after making all reasonable efforts, has been able to contact the employee, how many days must you wait before verifying a “no contact” positive?

Section 40.133(a)(3) states: “You may verify a test result as a positive or refusal to test, as applicable, if neither you nor the DER, after making and documenting all reasonable efforts, has been able to contact the employee within ten days of the date on which the MRO receives the confirmed test result from the laboratory.”

If an employee cannot be contacted, and a test is verified as a “no contact” positive, is the employee allowed to present to you information documenting that serious illness, injury, or other circumstances prevented the employee from contacting you, and if so, is there a time limit?

Section 40.133(c) states: “As the MRO, after you have verified a test result as a positive or refusal to test under this section and reported the result to the DER, you must allow the employee to present information to you within 60 days of the verification documenting that serious illness, injury, or other circumstances unavoidably precluded contact with the MRO and/or DER in the times provided. On the basis of such information, you may reopen the verification, allowing the employee to present information concerning whether there is a legitimate medical explanation for the confirmed test result.”

NOW I WOULD LIKE TO DISCUSS A FEW QUESTIONS ABOUT PROBLEMS IN TESTING

What are the verification requirements if the laboratory confirms the presence of an opiate?

Section 40.139 states: “(a) If the laboratory detects the presence of 6-acetylmorphine (6-AM) in the specimen, you must verify the test result positive.

(b) In the absence of 6-AM, if the laboratory detects the presence of either morphine or codeine at 15,000 ng/mL or above, you must verify the test result positive unless the employee presents a legitimate medical explanation for the presence of the drug or drug metabolite in his or her system, as in the case of other drugs (see Section 40.137). Consumption of food products (e.g., poppy seeds) must not be considered a legitimate medical explanation for the employee having morphine or codeine at these concentrations.

(c) For all other opiate positive results, you must verify a confirmed positive test result for opiates only if you determine that there is clinical evidence, in addition to the urine test, of unauthorized use of any opium, opiate, or opium derivative (i.e., morphine, heroin, or codeine).”

In the case of a “shy bladder,” where an employee can not provide an adequate specimen (at least 45 milliliters), do you have any involvement in determining whether the individual's ability to provide a specimen is genuine or constitutes a refusal to test?

Section 40.193(h) states: “As the MRO, you must seriously consider and assess the referral physician’s recommendations in making your determination about whether the employee has a medical condition that has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of urine. You must report your determination to the DER in writing as soon as you make it.”

If the laboratory reports that the specimen has been "rejected for testing" because of a fatal or uncorrected flaw, what test result do you report to the DER and under what circumstances would additional testing be required?

Section 40.161 states: “As the MRO, when the laboratory reports that the specimen is rejected for testing (e.g., because of a fatal or uncorrected flaw), you must do the following: . . .

(b) Report to the DER that the test is cancelled and the reason for cancellation, and that no further action is required unless a negative test is required (e.g., in the case of a pre-employment, return-to-duty, or follow-up test).”

Are there any "correctable flaws" that are the MRO’s responsibility to correct? If so, what are they?

Section 40.203(d) states: “The following are correctable flaws that you [the MRO] must attempt to correct:

(1) The employee's signature is omitted from the certification statement, unless the employee's failure or refusal to sign is noted on the “Remarks” line of the CCF.

(2) The certifying scientist's signature is omitted on the laboratory copy of the CCF for a positive, adulterated, substituted, or invalid test result.

(3) The collector uses a non-Federal form or an expired Federal form for the test.”

As a MRO, if you cancel a laboratory confirmed positive, adulterated, substituted, or invalid drug test report, what steps do you complete on the CCF?

Section 40.129(d) states: “If you [the MRO] cancel a laboratory confirmed positive, adulterated, substituted, or invalid drug test report, 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 of the verification statement.”

As a MRO, when the laboratory reports that a specimen is adulterated or substituted, are you required to conduct a verification procedure, and if so, what actions are you required to take?

Section 40.145 states: “(a) As an MRO, when you receive a laboratory report that a specimen is adulterated or substituted, you must treat that report in the same way you treat the laboratory's report of a confirmed positive test for a drug or drug metabolite.

(b) You must follow the same procedures used for verification of a confirmed positive test for a drug or drug metabolite except as otherwise provided in this section.”

Section 40.145(g) states: “(1) If you determine that the employee’s explanation does not present a reasonable basis for concluding that there may be a legitimate medical explanation, you must report the test to the DER as a verified refusal to test because of adulteration or substitution, as applicable.

(2) If you believe that the employee’s explanation may present a reasonable basis for concluding that there is a legitimate medical explanation, you must direct the employee to obtain, within the five-day period set forth in paragraph (e)(3) of this section, a further medical evaluation. This evaluation must be performed by a licensed physician (the “referral physician”), acceptable to you, with expertise in the medical issues raised by the employee’s explanation. (The MRO may perform this evaluation if the MRO has appropriate expertise.)”

As the MRO verifying a specimen reported adulterated by the laboratory, do YOU have the burden of proof that there is NO medical explanation for the presence of the adulterant in the specimen, or does the EMPLOYEE have the burden of proof that there IS a medical explanation for the presence of the adulterant in the specimen?

Section 40.145(e) states: “The employee has the burden of proof that there is a legitimate medical explanation.

(1) To meet this burden in the case of an adulterated specimen, the employee must demonstrate