§ 40.83 How do laboratories process incoming specimens?

As the laboratory, you must do the following when you receive a DOT specimen:
(a) EachYou employerare orauthorized itsto agentreceive shallonly maintainCopy 1 of the followingCCF. recordsYou forare twonot years:authorized to receive other copies of the CCF or any copies of the alcohol testing form.
(1b) RecordsYou must comply with applicable provisions of the inspectionHHS Guidelines concerning accessioning and maintenanceprocessing ofdrug specimens.
(c) You must inspect each EBTspecimen usedand inCCF employeefor testingthe following “fatal flaws”:
(1) There is no CCF;
(2) DocumentationIn ofcases where a specimen has been collected, there is no specimen submitted with the employerCCF;
(3) There is no printed collector's compliancename withand no collector's signature;
(4) Two separate collections are performed using one CCF;
(5) The specimen ID numbers on the QAPspecimen forbottle eachand EBTthe itCCF usesdo fornot alcoholmatch;
(6) testingThe underspecimen bottle seal is broken or shows evidence of tampering, unless a split specimen can be redesignated (see paragraph (h) of this partsection);
(37) RecordsThere is an insufficient amount of specimen in the trainingprimary andbottle proficiencyfor testinganalysis, unless the specimens can be redesignated (see paragraph (h) of eachthis BATsection).
(8) For an oral fluid collection, the collector used an expired device at the time of collection.
(9) For an oral fluid collection, if the collector failed to enter the expiration date in employeeStep 4 of the CCF and the laboratory is unable to determine the expiration date by inspecting Bottles A and B.
(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(b)(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) TheIn logsuch booksa requiredcase, 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 § 40.59205(cb)(1).
(3) If the flaw is not corrected, report the result as rejected for testing in accordance with § 40.97(b)(3).
(f) EachIf employeryou ordetermine itsthat agentthe shallurine maintainspecimen 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 yearsbusiness recordsdays, pertainingbefore 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(b).
(g) If you determine that a CCF that fails to meet the calibrationrequirements of each§ EBT40.40(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 problem(s) is not corrected, you must reject the test and report the result in alcoholaccordance with § 40.97(b)(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, underyou thismust partstill 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., includingBottle recordsB is redesignated as Bottle A, and vice-versa) if:
(i) The primary specimen appears to have leaked out of its sealed bottle and the resultslaboratory believes a sufficient amount of externalspecimen calibrationexists checks.in the split specimen to conduct all appropriate primary laboratory testing; or
(cii) RecordsThe requiredprimary 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 specimen exists in the split specimen to beconduct maintainedall byappropriate 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 specimen 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 disclosedmade 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 sameCCF basis(Step 5a) and on any laboratory internal chain of custody documents, as providedappropriate, infor §any 40fatal or correctable flaw.81
[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; 88 FR 27643, May 2, 2023; 89 FR 51983, June 21, 2024]