§ 40.31 Who may collect specimens for DOT drug testing?

(a) General.Collectors Drugmeeting testing laboratories shall have a quality assurance program which encompasses all aspects of the testingrequirements process including but not limited to specimen acquisition, chain of custodythis securitysubpart andare reportingthe ofonly results,persons initialauthorized and confirmatory testing and validation of analytical procedures. Quality assurance procedures shall be designed, implemented and reviewed to monitorcollect theurine conductspecimens offor eachDOT stepdrug of the process of testing for drugs.
(b) LaboratoryA qualityurine controlcollector requirementsmust formeet initialtraining tests.requirements Each analytical run of specimens§ to be screened shall include:40.33.
(1c) UrineAn specimensoral certifiedfluid tocollector containmust nomeet drug;
(2)the Urinetraining specimensrequirements fortifiedof with§ known standards; and40.35.
(3d) PositiveTo controlsavoid with the drugappearance or metabolite at or near the cutoff level.
In addition, with each batch of samples a sufficientconflict number of standardsinterest, shallif beyou includedare to ensure and document the linearityimmediate ofsupervisor the assay method over time in the concentration area of the cutoff.employee Afterbeing acceptable values are obtained for the known standardstested, thoseyou valuesmust will be used to calculate sample data. Implementation of procedures to ensure the carryover does not contaminateact theas testing of an individual's specimen shall be documented. A minimum of 10 percent of all test samples shall be quality control specimens. Laboratory quality control samples, prepared from spiked urine samples of determined concentration shall be included in the runcollector andwhen shouldthat appearemployee asis normal samples to laboratory analysts. One percent of each runtested, withunless a minimum of at least one sample, shall be the laboratory's own quality control samples.
(c) Laboratory quality control requirements for confirmation tests. Each analytical run of specimens to be confirmed shall include:
(1) Urine specimens certified to contain no drug;
(2)other Urinecollector specimensis fortifiedavailable with known standards; and
(3) Positiveyou controlsare withpermitted the drug or metabolite at or near the cutoff level. The linearity and precision of the method shall be periodically documented. Implementation of procedures to ensuredo thatso carryoverunder does not contaminate the testing of an individual's specimen shall also be documented.
(d) Employer blind performance test procedures. (1) Each employer covered by DOT agency drug testingand regulationsalcohol shall use blind testing quality control procedures as provided in this paragraphregulations.
(2e) EachYou employermust shallnot submitact threeas blindthe performancecollector test specimens for eachthe 100 employee specimensbeing ittested submits, up to a maximum of 100 blind performance test specimens submitted per quarter. A DOT agency may increase this per quarter maximum number of samples if doingyou sowork isfor necessarya toHHS-certified ensurelaboratory adequate quality control of employers or consortiums with very large numbers of employees.
(3) For employers with 2000 or more covered employees, approximately 80 percent of the blind performance test samples shall be blank (i.e.g., containing no drug or otherwise as approved by a DOTtechnician agencyor accessioner) and thecould remaininglink samples shall be positive for one or more drugs per sample in a distribution such that all the drugsemployee to be tested are included in approximately equal frequencies of challenge. The positive samples shall be spiked only with thosea drugsurine forspecimen, whichdrug the employer is testing. Thisresult, paragraphor shalllaboratory not be construed to prohibit spiking of other report.
(potentially interferingf) compounds,Employees asare technicallynot appropriate,permitted in order to verifybe thetheir specificityown of a particular assaycollector.
(41) EmployersAn withemployee fewerwho thanis 2000 covered employees may submit blind performance test specimens as provided in paragraph (d)(3) of this section. Such employers may also submit only blank samples or may submit two separately labeled portions of a specimenqualified fromcollector theis samenot non-coveredpermitted employee.
(5)to Consortiums shall be responsible for the submission of blind samples on behalf of their members.own Thecollector; blindanother samplingqualified ratecollector shallmust applyperform to the totalcollection numberin ofaccordance sampleswith submittedthis by the consortiumpart.
(62) TheTo DOTavoid agencya concernedpotential shallconflict investigate, or shall refer to DHHS for investigation, any unsatisfactory performance testing result and, based on this investigation, the laboratory shall take action to correct the cause of the unsatisfactory performance test result. A record shall be made of the investigative findings and the corrective action taken by the laboratoryinterest, anda thatcollector recordmust shallnot be datedrelated and signed by the individual responsible for the day-to-day management and operation of the drugemployee testingbeing laboratory.tested Then the DOT agency shall send the document to the employer as a report of the unsatisfactory performance testing incident. The DOT agency shall ensure notification of the finding to DHHS.
(7) Should a false positive error occur on a blind performance test specimen and the error is determined to be an administrative error (clerical, sample mixup, etce.), the employer shall promptly notify the DOT agency concernedg. The DOT agency and the employer shall require the laboratory to take corrective action to minimize the occurrence of the particular error in the future, andspouse, if there is reason to believe the error could have been systemicex-spouse, therelative) DOTor agencya mayclose alsopersonal require review and reanalysis of previously run specimensfriend.
(8)[65 ShouldFR a false positive error occur on a blind performance test specimen and the error is determined to be a technical or methodological error79526, the employer shall instruct the laboratory to submit all quality control data from the batch of specimens which included the false positive specimen to the DOT agency concernedDec. In19, addition2000, theas laboratoryamended shallat retest88 allFR specimens analyzed positive for that drug or metabolite from the time of final resolution of the error back to the time of the last satisfactory performance test cycle. This retesting shall be documented by a statement signed by the individual responsible for day-to-day management of the laboratory's urine drug testing. The DOT agency concerned may require an on-site review of the laboratory which may be conducted unannounced during any hours of operation of the laboratory. Based on information provided by the DOT agency27637, DHHSMay has the option of revoking or suspending the laboratory's certification or recommending that no further action be taken if the case is one of less serious error in which corrective action has already been taken2, thus reasonably assuring that the error will not occur again.2023]