[Code of Federal Regulations]

[Title 49, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 49CFR40.97]



[Page 653-654]

 

                        TITLE 49--TRANSPORTATION

 

          Subtitle A--Office of the Secretary of Transportation

 

PART 40_PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING 

PROGRAMS--Table of Contents

 

                   Subpart F_Drug Testing Laboratories

 

Sec. 40.97  What do laboratories report and how do they report it?



    (a) As a laboratory, you must report the results for each primary 

specimen tested as one or more of the following:

    (1) Negative;

    (2) Negative-dilute, with numerical values for creatinine and 

specific gravity;

    (3) Rejected for testing, with remark(s);

    (4) Positive, with drug(s)/metabolite(s) noted;

    (5) Positive, with drug(s)/metabolite(s) noted--dilute;

    (6) Adulterated, with numerical values (when applicable), with 

remark(s);

    (7) Substituted, with numerical values for creatinine and specific 

gravity; or

    (8) Invalid result, with remark(s).

    (b) 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).

    (1) Negative results: 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, or you may 

provide the laboratory results report electronically (i.e., computer 

data file).

    (i) If you elect to provide the laboratory results report, you must 

include the following elements, as a minimum, in the report format:

    (A) Laboratory name and address;

    (B) Employer's name (you may include I.D. or account number);

    (C) Medical review officer's name;

    (D) Specimen I.D. number;

    (E) Donor's SSN or employee I.D. number, if provided;

    (F) Reason for test, if provided;

    (G) Collector's name and telephone number;

    (H) Date of the collection;

    (I) Date received at the laboratory;

    (J) Date certifying scientist released the results;

    (K) Certifying scientist's name;

    (L) Results (e.g., positive, adulterated) as listed in paragraph (a) 

of this section; and

    (M) Remarks section, with an explanation of any situation in which a 

correctable flaw has been corrected.

    (ii) You may release the laboratory results report only after review 

and approval by the certifying scientist. It must reflect the same test 

result information as contained on the CCF signed by the certifying 

scientist. The information contained in the laboratory results report 

may not contain information that does not appear on the CCF.

    (iii) The results report may be transmitted through any means that 

ensures accuracy and confidentiality. You, as the laboratory, together 

with the MRO, must ensure that the information is adequately protected 

from unauthorized access or release, both during transmission and in 

storage.

    (2) Non-negative results: You must fax, courier, mail, or 

electronically transmit a legible image or copy of the fully-completed 

Copy 1 of the CCF that has been signed by the certifying scientist. In 

addition, you may provide the electronic laboratory results report 

following the format and procedures set forth in paragraphs (b)(1)(i) 

and (ii) of this section.



[[Page 654]]



    (c) In transmitting laboratory results to the MRO, you, as the 

laboratory, together with the MRO, must ensure that the information is 

adequately protected from unauthorized access or release, both during 

transmission and in storage. If the results are provided by fax, the fax 

connection must have a fixed telephone number accessible only to 

authorized individuals.

    (d) You must transmit test results to the MRO in a timely manner, 

preferably the same day that review by the certifying scientist is 

completed.

    (e)(1) You must provide quantitative values for confirmed positive 

drug test results to the MRO when the MRO requests you to do so in 

writing. The MRO's request may be either a general request covering all 

such results you send to the MRO or a specific case-by-case request.

    (2) You must provide the numerical values that support the 

adulterated (when applicable) or substituted result, without a request 

from the MRO.

    (3) You must also provide to the MRO numerical values for creatinine 

and specific gravity for the negative-dilute test result, without a 

request from the MRO.

    (f) You must provide quantitative values for confirmed opiate 

results for morphine or codeine at 15,000 ng/mL or above, even if the 

MRO has not requested quantitative values for the test result.



[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001; 68 

FR 31626, May 28, 2003; 69 FR 64867, Nov. 9, 2004]