Implementation Guidelines - Federal Transit Administration - U.S. ...
Implementation Guidelines - Federal Transit Administration - U.S. ... Implementation Guidelines - Federal Transit Administration - U.S. ...
Page 29 of 100 (i) If you became an MRO before August 1, 2001, and have already met the qualification training requirement, you do not have to meet it again. (ii) If you became an MRO before August 1, 2001, but have not yet met the qualification training requirement, you must do so no later than January 31, 2003. (iii) 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. (d) Continuing Education. During each three-year period from the date on which you 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. (1) This continuing education must include material concerning new technologies, interpretations, recent guidance, rule changes, and other information about developments in MRO practice, pertaining to the DOT program, since the time you met the qualification training requirements of this section. (2) Your continuing education activities must include assessment tools to assist you in determining whether you have adequately learned the material. (3) If you are an MRO who completed the qualification training and examination requirements prior to August 1, 2001, you must complete your first increment of 12 CEU hours before August 1, 2004. (e) Documentation. You 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. [65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001; 73 FR 33329, June 12, 2008] § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO, you have the following basic responsibilities: (a) Acting as an independent and impartial “gatekeeper” and advocate for the accuracy and integrity of the drug testing process. (b) Providing a quality assurance review of the drug testing process for the specimens under your purview. This includes, but is not limited to: (1) Ensuring the review of the CCF on all specimen collections for the purposes of determining whether there is a problem that may cause a test to be cancelled (see §§40.199–40.203). As an MRO, you are not required to review laboratory internal chain of custody documentation. No one is permitted to cancel a test because you have not reviewed this documentation; (2) Providing feedback to employers, collection sites and laboratories regarding performance issues where necessary; and (3) Reporting to and consulting with the ODAPC or a relevant DOT agency when you wish DOT assistance in resolving any program issue. As an employer or service agent, you are prohibited from limiting or attempting to limit the MRO's access to DOT for this purpose and from retaliating in any way against an MRO for discussing drug testing issues with DOT. (c) You must determine whether there is a legitimate medical explanation for confirmed positive, adulterated, substituted, and invalid drug tests results from the laboratory. (d) While you provide medical review of employees' test results, this part does not deem that you have established a doctor-patient relationship with the employees whose tests you review. (e) You must act to investigate and correct problems where possible and notify appropriate parties (e.g., HHS, DOT, employers, service agents) where assistance is needed, (e.g., cancelled or problematic tests, incorrect results, problems with blind specimens). (f) You must ensure the timely flow of test results and other information to employers. (g) You must protect the confidentiality of the drug testing information. (h) You must perform all your functions in compliance with this part and other DOT agency regulations. § 40.125 What relationship may an MRO have with a laboratory? 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 §40.101(b). § 40.127 What are the MRO's functions in reviewing negative test results? As the MRO, you must do the following with respect to negative drug test results you receive from a laboratory, prior to verifying the result and releasing it to the DER:
Page 30 of 100 (a) Review Copy 2 of the CCF to determine if there are any fatal or correctable errors that may require you to initiate corrective action or to cancel the test (see §§40.199 and 40.203). (b) Review the negative laboratory test result and ensure that it is consistent with the information contained on the CCF. (c) Before you report a negative test result, 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 or the electronic laboratory results report that conveys the negative laboratory test result. (d) 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. (e) On Copy 2 of the CCF, place a check mark in the “Negative” box (Step 6), provide your name, and sign, initial, or stamp and date the verification statement. (f) Report the result in a confidential manner (see §§40.163–40.167). (g) Staff under your direct, personal supervision may perform the administrative functions of this section for you, but only you can cancel a test. If you cancel a laboratory-confirmed negative result, check the “Test Cancelled” box (Step 6) on Copy 2 of the CCF, make appropriate annotation in the “Remarks” line, provide your name, and sign, initial or stamp and date the verification statement. (1) On specimen results that are reviewed by your staff, you are responsible for assuring the quality of their work. (2) You 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. (3) Your 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. (4) You must make these CCFs easily identifiable and retrievable by you for review by DOT agencies. [65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001] § 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 drug tests 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 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. (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. (5) Verify the test result, consistent with the requirements of §§ 40.135 through 40.145, 40.159, and 40.160, as: (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, test cancelled, 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 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.
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Page 29 of 100<br />
(i) If you became an MRO before August 1, 2001, and have already met the qualification training<br />
requirement, you do not have to meet it again.<br />
(ii) If you became an MRO before August 1, 2001, but have not yet met the qualification training<br />
requirement, you must do so no later than January 31, 2003.<br />
(iii) If you become an MRO on or after August 1, 2001, you must meet the qualification training<br />
requirement before you begin to perform MRO functions.<br />
(d) Continuing Education. During each three-year period from the date on which you satisfactorily<br />
complete the examination under paragraph (c)(2) of this section, you must complete continuing education consisting<br />
of at least 12 professional development hours (e.g., Continuing Education Medical Units) relevant to performing<br />
MRO functions.<br />
(1) This continuing education must include material concerning new technologies, interpretations, recent<br />
guidance, rule changes, and other information about developments in MRO practice, pertaining to the DOT<br />
program, since the time you met the qualification training requirements of this section.<br />
(2) Your continuing education activities must include assessment tools to assist you in determining whether<br />
you have adequately learned the material.<br />
(3) If you are an MRO who completed the qualification training and examination requirements prior to<br />
August 1, 2001, you must complete your first increment of 12 CEU hours before August 1, 2004.<br />
(e) Documentation. You must maintain documentation showing that you currently meet all requirements of<br />
this section. You must provide this documentation on request to DOT agency representatives and to employers and<br />
C/TPAs who are using or negotiating to use your services.<br />
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001; 73 FR 33329, June 12, 2008]<br />
§ 40.123 What are the MRO's responsibilities in the DOT drug testing program?<br />
As an MRO, you have the following basic responsibilities:<br />
(a) Acting as an independent and impartial “gatekeeper” and advocate for the accuracy and integrity of the<br />
drug testing process.<br />
(b) Providing a quality assurance review of the drug testing process for the specimens under your purview.<br />
This includes, but is not limited to:<br />
(1) Ensuring the review of the CCF on all specimen collections for the purposes of determining whether<br />
there is a problem that may cause a test to be cancelled (see §§40.199–40.203). As an MRO, you are not required to<br />
review laboratory internal chain of custody documentation. No one is permitted to cancel a test because you have<br />
not reviewed this documentation;<br />
(2) Providing feedback to employers, collection sites and laboratories regarding performance issues where<br />
necessary; and<br />
(3) Reporting to and consulting with the ODAPC or a relevant DOT agency when you wish DOT assistance<br />
in resolving any program issue. As an employer or service agent, you are prohibited from limiting or attempting to<br />
limit the MRO's access to DOT for this purpose and from retaliating in any way against an MRO for discussing drug<br />
testing issues with DOT.<br />
(c) You must determine whether there is a legitimate medical explanation for confirmed positive,<br />
adulterated, substituted, and invalid drug tests results from the laboratory.<br />
(d) While you provide medical review of employees' test results, this part does not deem that you have<br />
established a doctor-patient relationship with the employees whose tests you review.<br />
(e) You must act to investigate and correct problems where possible and notify appropriate parties (e.g.,<br />
HHS, DOT, employers, service agents) where assistance is needed, (e.g., cancelled or problematic tests, incorrect<br />
results, problems with blind specimens).<br />
(f) You must ensure the timely flow of test results and other information to employers.<br />
(g) You must protect the confidentiality of the drug testing information.<br />
(h) You must perform all your functions in compliance with this part and other DOT agency regulations.<br />
§ 40.125 What relationship may an MRO have with a laboratory?<br />
As an MRO, you may not enter into any relationship with an employer's laboratory that creates a conflict of<br />
interest or the appearance of a conflict of interest with your responsibilities to that employer. You may not derive<br />
any financial benefit by having an employer use a specific laboratory. For examples of relationships between<br />
laboratories and MROs that the Department views as creating a conflict of interest or the appearance of such a<br />
conflict, see §40.101(b).<br />
§ 40.127 What are the MRO's functions in reviewing negative test results?<br />
As the MRO, you must do the following with respect to negative drug test results you receive from a<br />
laboratory, prior to verifying the result and releasing it to the DER: