Subpart F - Drug Testing Laboratories
Link to an amendment published at 88 FR 27643, May 2, 2023.
§ 40.81 What laboratories may be used for DOT drug testing? Cross Reference Link to an amendment published at 88 FR 27643, May 2, 2023.
(a) As a drug testing laboratory located in the U.S., you are permitted to participate in DOT drug testing only if you are certified by HHS under the National Laboratory Certification Program (NLCP) for all testing required under this part.
(b) As a drug testing laboratory located in Canada or Mexico that is not certified by HHS under the NLCP, you are permitted to participate in DOT drug testing only if:
(1) The DOT, based on a written recommendation from HHS, has approved your laboratory as meeting HHS laboratory certification standards or deemed your laboratory fully equivalent to a laboratory meeting HHS laboratory certification standards for all testing required under this part; or
(2) The DOT, based on a written recommendation from HHS, has recognized a Canadian or Mexican certifying organization as having equivalent laboratory certification standards and procedures to those of HHS, and the Canadian or Mexican certifying organization has certified your laboratory under those equivalent standards and procedures.
(c) As a laboratory participating in the DOT drug testing program, you must comply with the requirements of this part. You must also comply with all applicable requirements of HHS in testing DOT specimens, whether or not the HHS requirements are explicitly stated in this part.
(d) If DOT determines that you are in noncompliance with this part, you could be subject to PIE proceedings under Subpart R of this part. If the Department issues a PIE with respect to you; you are ineligible to participate in the DOT drug testing program even if you continue to meet the requirements of paragraph (a) or (b) of this section.
§ 40.83 How do laboratories process incoming specimens? Cross Reference Link to an amendment published at 88 FR 27643, May 2, 2023.
As the laboratory, you must do the following when you receive a DOT specimen:
(a) You are authorized to receive only Copy 1 of the CCF. You are not authorized to receive other copies of the CCF or any copies of the alcohol testing form.
(b) You must comply with applicable provisions of the HHS Guidelines concerning accessioning and processing urine drug specimens.
(c) You must inspect each specimen and CCF for the following “fatal flaws”:
(1) There is no CCF;
(2) In cases where a specimen has been collected, there is no specimen submitted with the CCF;
(3) There is no printed collector's name and no collector's signature;
(4) Two separate collections are performed using one CCF;
(5) The specimen ID numbers on the specimen bottle and the CCF do not match;
(6) The specimen bottle seal is broken or shows evidence of tampering, unless a split specimen can be redesignated (see paragraph (h) of this section);
(7) There is an insufficient amount of urine in the primary bottle for analysis, unless the specimens can be redesignated (see paragraph (h) of this section).
(d) When you find a specimen meeting the criteria of paragraph (c) of this section, you must document your findings and stop the testing process. Report the result in accordance with § 40.97(a)(3).
(e) You must inspect each CCF for the presence of the collector's signature on the certification statement in Step 4 of the CCF. Upon finding that the signature is omitted, document the flaw and continue the testing process.
(1) In such a case, you must retain the specimen for a minimum of 5 business days from the date on which you initiated action to correct the flaw.
(2) You must then attempt to correct the flaw by following the procedures of § 40.205(b)(1).
(3) If the flaw is not corrected, report the result as rejected for testing in accordance with § 40.97(a)(3).
(f) If you determine that the specimen temperature was not checked and the “Remarks” line did not contain an entry regarding the temperature being outside of range, you must then attempt to correct the problem by following the procedures of § 40.208.
(1) In such a case, you must continue your efforts to correct the problem for five business days, before you report the result.
(2) When you have obtained the correction, or five business days have elapsed, report the result in accordance with § 40.97(a).
(g) If you determine that a CCF that fails to meet the requirements of § 40.45(a) (e.g., a non-Federal form or an expired Federal form was used for the collection), you must attempt to correct the use of the improper form by following the procedures of § 40.205(b)(2).
(1) In such a case, you must retain the specimen for a minimum of 5 business days from the date on which you initiated action to correct the problem.
(2) If the problems are not corrected, you must reject the test and report the result in accordance with § 40.97(a)(3).
(h) If the CCF is marked indicating that a split specimen collection was collected and if the split specimen does not accompany the primary, has leaked, or is otherwise unavailable for testing, you must still test the primary specimen and follow appropriate procedures outlined in § 40.175(b) regarding the unavailability of the split specimen for testing.
(1) The primary specimen and the split specimen can be redesignated (i.e., Bottle B is redesignated as Bottle A, and vice versa) if:
(i) The primary specimen appears to have leaked out of its sealed bottle and the laboratory believes a sufficient amount of urine exists in the split specimen to conduct all appropriate primary laboratory testing; or
(ii) The primary specimen is labeled as Bottle B, and the split specimen as Bottle A; or
(iii) The laboratory opens the split specimen instead of the primary specimen, the primary specimen remains sealed, and the laboratory believes a sufficient amount of urine exists in the split specimen to conduct all appropriate primary laboratory testing; or
(iv) The primary specimen seal is broken but the split specimen remains sealed and the laboratory believes a sufficient amount of urine exists in the split specimen to conduct all appropriate primary laboratory testing.
(2) In situations outlined in paragraph (h)(1) of this section, the laboratory shall mark through the “A” and write “B,” then initial and date the change. A corresponding change shall be made to the other bottle by marking through the “B” and writing “A,” and initialing and dating the change.
(i) A notation shall be made on Copy 1 of the CCF (Step 5a) and on any laboratory internal chain of custody documents, as appropriate, for any fatal or correctable flaw.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001; 71 FR 49384, Aug. 23, 2006; 73 FR 35970, June 25, 2008; 75 FR 59107, Sept. 27, 2010; 82 FR 52244, Nov. 13, 2017]
§ 40.85 What drugs do laboratories test for? Cross Reference Link to an amendment published at 88 FR 27643, May 2, 2023.
As a laboratory, you must test for the following five drugs or classes of drugs in a DOT drug test. You must not test “DOT specimens” for any other drugs.
(a) Marijuana metabolites.
(b) Cocaine metabolites.
(c) Amphetamines.
(d) Opioids.
(e) Phencyclidine (PCP).
[82 FR 52244, Nov. 13, 2017]
§ 40.87 What are the cutoff concentrations for drug tests? Cross Reference Link to an amendment published at 88 FR 27643, May 2, 2023.
(a) As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:
Initial test analyte Initial test cutoff Confirmatory test analyte Confirmatory test cutoff concentration
Marijuana metabolites (THCA)² 50 ng/mL THCA 15 ng/mL.
Cocaine metabolite (Benzoylecgonine) 150 ng/mL Benzoylecgonine 100 ng/mL.
Codeine/Morphine 2000 ng/mL Codeine 2000 ng/mL. Morphine 2000 ng/mL.
Hydrocodone/Hydromorphone 300 ng/mL Hydrocodone 100 ng/mL. Hydromorphone 100 ng/mL.
Oxycodone/Oxymorphone 100 ng/mL Oxycodone 100 ng/mL. Oxymorphone 100 ng/mL.
6-Acetylmorphine 10 ng/mL 6-Acetylmorphine 10 ng/mL.
Phencyclidine 25 ng/mL Phencyclidine 25 ng/mL.
Amphetamine/Methamphetamine 500 ng/mL Amphetamine 250 ng/mL. Methamphetamine 250 ng/mL.
MDMA⁴/MDA⁵ 500 ng/mL MDMA 250 ng/mL. MDA 250 ng/mL.
1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.
2 An immunoassay must be calibrated with the target analyte, Δ-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
3 Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial and confirmatory tests (i.e., 15 ng/mL for THCA and 100 ng/mL for Benzoylecgonine).
4 Methylenedioxymethamphetamine (MDMA).
5 Methylenedioxyamphetamine (MDA).
(b) On an initial drug test, you must report a result below the cutoff concentration as negative. If the result is at or above the cutoff concentration, you must conduct a confirmation test.
(c) On a confirmation drug test, you must report a result below the cutoff concentration as negative and a result at or above the cutoff concentration as confirmed positive.
(d) You must report quantitative values for morphine or codeine at 15,000 ng/mL or above.
[65 FR 79526, Dec. 19, 2000, as amended at 75 FR 49862, Aug. 16, 2010; 77 FR 26473, May 4, 2012; 82 FR 52244, Nov. 13, 2017]
§ 40.89 What is validity testing, and are laboratories required to conduct it? Cross Reference Link to an amendment published at 88 FR 27643, May 2, 2023.
(a) Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine. The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the urine, if the urine was diluted, or if the specimen was substituted.
(b) As a laboratory, you must conduct validity testing.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41951, Aug. 9, 2001; 73 FR 35970, June 25, 2008]
§ 40.91 What validity tests must laboratories conduct on primary specimens? Cross Reference Link to an amendment published at 88 FR 27643, May 2, 2023.
As a laboratory, when you conduct validity testing under § 40.89, you must conduct it in accordance with the requirements of this section.
(a) You must determine the creatinine concentration on each primary specimen. You must also determine its specific gravity if you find the creatinine concentration to be less than 20 mg/dL.
(b) You must determine the pH of each primary specimen.
(c) You must perform one or more validity tests for oxidizing adulterants on each primary specimen.
(d) You must perform additional validity tests on the primary specimen when the following conditions are observed:
(1) Abnormal physical characteristics;
(2) Reactions or responses characteristic of an adulterant obtained during initial or confirmatory drug tests (e.g., non-recovery of internal standards, unusual response); or
(3) Possible unidentified interfering substance or adulterant.
(e) If you determine that the specimen is invalid and HHS guidelines direct you to contact the MRO, you must contact the MRO and together decide if testing the primary specimen by another HHS-certified laboratory would be useful in being able to report a positive or adulterated test result.
[65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
Cross-Reference: link to the amendment published at 88 FR 27643 (May 2, 2023).
(a) As a laboratory, you must consider the primary specimen dilute when:
(1) The creatinine concentration is ≥ 2 mg/dL but < 20 mg/dL, and
(2) The specific gravity is > 1.0010 and < 1.0030 on a single aliquot.
(b) As a laboratory, you must consider the primary specimen substituted when creatinine concentration is < 2 mg/dL and specific gravity is ≤ 1.0010 or ≥ 1.0200 on both initial and confirmatory creatinine and specific gravity tests on two separate aliquots.
[69 FR 64867, Nov. 9, 2004]
§ 40.95 What are the adulterant cutoff concentrations for initial and confirmation tests?
Cross-Reference: link to the amendment published at 88 FR 27643 (May 2, 2023).
(a) As a laboratory, you must use the initial- and confirmation-test cutoff concentrations for adulterant testing as required by HHS Mandatory Guidelines, and you must use two separate aliquots—one for the initial test and another for the confirmation test.
(b) As a laboratory, you must report results at or above the cutoffs (or for pH, at or above or below the values, as appropriate) as adulterated and provide the numerical value that supports the adulterated result.
[73 FR 35970, June 25, 2008]
§ 40.96 What criteria do laboratories use to establish that a specimen is invalid?
Cross-Reference: link to the amendment published at 88 FR 27643 (May 2, 2023).
(a) As a laboratory, you must use invalid test result criteria for initial and confirmation testing as required by HHS Mandatory Guidelines, and you must use two separate aliquots—one for the initial test and another for the confirmation test.
(b) As a laboratory, if a specimen has an invalid result for any reason outlined in HHS Mandatory Guidelines, you must contact the MRO to discuss whether sending it to another HHS-certified laboratory would be useful in being able to report a positive or adulterated result.
(c) As a laboratory, you must report invalid results in accordance with the criteria required by HHS Guidelines and provide the numerical value that supports the invalid result, where appropriate, such as pH.
(d) As a laboratory, you must report the reason a test result is invalid.
[73 FR 35970, June 25, 2008]
§ 40.97 What do laboratories report and how do they report it?
Cross-Reference: link to the amendment published at 88 FR 27644 (May 2, 2023).
(a) As a laboratory, you must report the results for each primary specimen. The result of a primary specimen will fall into one of the following three categories. However, you must report the actual results (not the categories):
(1) Category 1: Negative Results. As a laboratory, when you find a specimen negative, you must report the test result as:
(i) Negative, or
(ii) Negative-dilute, with numerical values for creatinine and specific gravity.
(2) Category 2: Non-negative Results. As a laboratory, when you find a specimen non-negative, you must report the test result as one or more of the following:
(i) Positive, with drug(s)/metabolite(s) noted and numerical values;
(ii) Positive-dilute, with drug(s)/metabolite(s) noted, numerical values, and numerical values for creatinine and specific gravity;
(iii) Adulterated, with adulterant(s) noted, confirmatory test values (when applicable), and remark(s);
(iv) Substituted, with confirmatory test values for creatinine and specific gravity; or
(v) Invalid result, with remark(s). Laboratories must report actual pH values.
(3) Category 3: Rejected for Testing. As a laboratory, when you reject a specimen, report the result as Rejected for Testing, with remark(s).
(b) As a laboratory, you must report results directly—and only—to the MRO at their place of business. You must not report results to or through the DER or a service agent (e.g., C/TPA).
(1) Negative results: fax, courier, mail, or electronically transmit a legible image or copy of the fully completed Copy 1 of the CCF signed by the certifying scientist, or provide the electronic laboratory report.
(i) If you elect to provide an electronic laboratory report, you must include, at minimum, the following:
(A) Laboratory name and address;
(B) Employer's name (you may include ID or account number);
(C) Medical review officer's name;
(D) Specimen ID number;
(E) Donor's SSN or employee ID number, if provided;
(F) Reason for test, if provided;
(G) Collector's name and telephone number;
(H) Date of collection;
(I) Date received at the laboratory;
(J) Date certifying scientist released the results;
(K) Name of certifying scientist;
(L) Results (e.g., positive, adulterated) as listed in paragraph (a); and
(M) Remarks, with explanation of any situation in which a correctable flaw has been corrected.
(ii) You may release the report only after review and approval by the certifying scientist. It must reflect the same test result information as on the CCF signed by the certifying scientist. The report may not contain information that does not appear on the CCF.
(iii) The report may be transmitted through any means that ensures accuracy and confidentiality. You and the MRO must ensure the information is protected from unauthorized access or release, during transmission and in storage.
(2) Non-negative and Rejected for Testing results: fax, courier, mail, or electronically transmit a legible image or copy of the fully completed Copy 1 of the CCF signed by the certifying scientist. You may also provide the electronic report following paragraphs (b)(1)(i) and (ii).
(c) You and the MRO must ensure that results are protected from unauthorized access or release, during transmission and in storage. If 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) Provide quantitative values for confirmed positive drug test results to the MRO.
(2) Provide numerical values that support adulterated (when applicable) or substituted results, without an MRO request.
(3) Provide numerical values for creatinine and specific gravity for negative-dilute results, without an MRO request.
(f) 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 them.
[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; 73 FR 35970, June 25, 2008; 75 FR 49862, Aug. 16, 2010; 75 FR 59107, Sept. 27, 2010; 77 FR 26473, May 4, 2012]
§ 40.99 How long does the laboratory retain specimens after testing?
Cross Reference
Link to an amendment published at 88 FR 27643, May 2, 2023.
(a) As a laboratory testing the primary specimen, you must retain a specimen that was reported with positive, adulterated, substituted, or invalid results for a minimum of one year.
(b) You must keep such a specimen in secure, long-term, frozen storage in accordance with HHS requirements.
(c) Within the one-year period, the MRO, the employee, the employer, or a DOT agency may request in writing that you retain a specimen for an additional period of time (e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you receive such a request, you must comply with it. If you do not receive such a request, you may discard the specimen at the end of the year.
(d) If you have not sent the split specimen to another laboratory for testing, you must retain the split specimen for an employee's test for the same period of time that you retain the primary specimen and under the same storage conditions.
(e) As the laboratory testing the split specimen, you must meet the requirements of paragraphs (a) through (d) of this section with respect to the split specimen.
§ 40.101 What relationship may a laboratory have with an MRO?
(a) As a laboratory, you may not enter into any relationship with an MRO that creates a conflict of interest or the appearance of a conflict of interest with the MRO's responsibilities for the employer. You may not derive any financial benefit by having an employer use a specific MRO.
(b) The following are examples of relationships between laboratories and MROs that the Department regards as creating conflicts of interest, or the appearance of such conflicts. This following list of examples is not intended to be exclusive or exhaustive:
(1) The laboratory employs an MRO who reviews test results produced by the laboratory;
(2) The laboratory has a contract or retainer with the MRO for the review of test results produced by the laboratory;
(3) The laboratory designates which MRO the employer is to use, gives the employer a slate of MROs from which to choose, or recommends certain MROs;
(4) The laboratory gives the employer a discount or other incentive to use a particular MRO;
(5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory; or
(6) The laboratory permits an MRO, or an MRO's organization, to have a financial interest in the laboratory.
§ 40.107 Who may inspect laboratories?
As a laboratory, you must permit an inspection, with or without prior notice, by ODAPC, a DOT agency, or a DOT-regulated employer that contracts with the laboratory for drug testing under the DOT drug testing program, or the designee of such an employer.
§ 40.109 What documentation must the laboratory keep, and for how long?
(a) As a laboratory, you must retain all records pertaining to each employee urine specimen for a minimum of two years.
(b) As a laboratory, you must also keep for two years employer-specific data required in § 40.111.
(c) Within the two-year period, the MRO, the employee, the employer, or a DOT agency may request in writing that you retain the records for an additional period of time (e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you receive such a request, you must comply with it. If you do not receive such a request, you may discard the records at the end of the two-year period.
§ 40.111 When and how must a laboratory disclose statistical summaries and other information it maintains?
Cross Reference
Link to an amendment published at 88 FR 27645, May 2, 2023.
(a) As a laboratory, you must transmit an aggregate statistical summary, by employer, of the data listed in Appendix B to this part to the employer on a semi-annual basis.
(1) The summary must not reveal the identity of any employee.
(2) In order to avoid sending data from which it is likely that information about an employee's test result can be readily inferred, you must not send a summary if the employer has fewer than five aggregate tests results.
(3) The summary must be sent by January 20 of each year for July 1 through December 31 of the prior year.
(4) The summary must also be sent by July 20 of each year for January 1 through June 30 of the current year.
(b) When the employer requests a summary in response to an inspection, audit, or review by a DOT agency, you must provide it unless the employer had fewer than five aggregate test results. In that case, you must send the employer a report indicating that not enough testing was conducted to warrant a summary. You may transmit the summary or report by hard copy, fax, or other electronic means.
(c) You must also release information to appropriate parties as provided in §§ 40.329 and 40.331.
(d) As a laboratory, you must transmit an aggregate statistical summary of the data listed in Appendix C to this part to DOT on a semi-annual basis. The summary must be sent by January 31 of each year for July 1 through December 31 of the prior year; it must be sent by July 31 of each year for January 1 through June 30 of the current year.
[65 FR 79526, Dec. 19, 2000, as amended at 73 FR 35971, June 25, 2008]
§ 40.113 Where is other information concerning laboratories found in this regulation?
You can find more information concerning laboratories in several sections of this part:
§ 40.3—Definition.
§ 40.13—Prohibition on making specimens available for other purposes.
§ 40.31—Conflicts of interest concerning collectors.
§ 40.47—Laboratory rejections of test for improper form.
§ 40.125—Conflicts of interest concerning MROs.
§ 40.175—Role of first laboratory in split specimen tests.
§ 40.177—Role of second laboratory in split specimen tests (drugs).
§ 40.179—Role of second laboratory in split specimen tests (adulterants).
§ 40.181—Role of second laboratory in split specimen tests (substitution).
§§ 40.183–40.185—Transmission of split specimen test results to MRO.
§§ 40.201–40.205—Role in correcting errors.