[Code of Federal Regulations]
[Title 49, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 49CFR40.97]

[Page 616-617]
 
                        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;
    (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 remark(s);
    (7) Substituted, with quantitative values for creatinine and 
specific gravity, and remarks; 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.
    (c) In transmitting laboratory results to the MRO, you, as the 
laboratory, together with the MRO, must ensure that

[[Page 617]]

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 and adulterated 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 also provide to the MRO quantitative values for 
creatinine and specific gravity for all substituted test results when 
the result is above your detection limit. If the result is not above 
your detection limit, you must report ``creatinine not detected'' to the 
MRO. You must make these reports for in all cases of substituted tests, 
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]