§ 40.73 How is an oral fluid specimen collected?
Current wording, effective December 5, 2024.
(a) AsThe the collector, you must dobe thepresent followingand thingsmaintain tovisual completecontact with the collectionemployee process.during You must complete the stepsprocedures calledoutlined for in paragraphsthis section.
(a)(1) throughAs (a)(7)the oforal thisfluid sectioncollector, inyou themust employee'snot presence.allow
(1)Directany person other than you, the employee, toor reada andDOT signagency therepresentative certificationto statementactually onwitness Copythe 2testing process.
(Step2) 5[Reserved]
(b) ofThe thecollector CCFmust andnote provideany dateunusual ofbehavior birth,or printedappearance name,of andthe dayemployee andon eveningthe contact telephone numbersCCF. If the employeecollector refusesdetects toany signconduct thethat CCFclearly orindicates toan provideattempt dateto oftamper birth,with printeda namespecimen (e.g., oran telephoneattempt numbers,to youbring mustinto notethe thiscollection insite thean “Remarks”adulterant lineor (Steporal 2fluid substitute), ofthe collector must terminate the CCF,collection and completereport the collection.information Ifto the employeeDER refusesso that the employer can decide whether to filldeem outthe anysituation information,a yourefusal.
(c) The employee and collector must, ascomplete athe minimum,specimen printcollection in accordance with the employeemanufacturer's nameinstructions infor the appropriatecollection placedevice.
(21) CompleteUnder the chainobservation of custodythe oncollector, the CCFemployee (Stepis 5)responsible byfor printingpositioning yourthe namespecimen (note:collection youdevice mayfor pre-printcollection.
(2) yourThe name),collector recordingmust ensure the timecollection andis dateperformed ofcorrectly the collection(i.e., signingusing the statement,oral andfluid enteringdevice in the namemanner ofdescribed theby deliveryits servicemanufacturer), transferringthat the specimencollection todevice theis laboratoryworking properly,
(3)Ensureand that alla copiessufficient ofspecimen thevolume CCFis are legible and completecollected.
(4)RemoveAfter Copy 5 of the CCFemployee andprovides givea itsufficient tospecimen, check the employee.“Volume Indicator(5s) PlaceObserved” thebox specimenin bottlesStep and2 Copy 1 of the Federal CCF into thedocument appropriatethat pouchesyou ofobserved the plasticvolume bag.indicator(6s) Secureduring both pouches of the plastic bagcollection.
(73) AdviseIf the employee states that he or she mayis leaveunable theto collectionprovide site.an
(8)Tooral preparefluid thespecimen sealedor plasticprovides bagan containinginsufficient thespecimen specimensduring andthe CCFcollection forprocess, shipmentthe youcollector must:
(i)Placecontinue theto sealedmake plasticone bagattempt into a shipping container (e.g.collect, standardafter courieran box)insufficient designedspecimen, tothe minimizecollector follows the possibilityprocedure ofin damage§ during shipment40. 193.
(More4) thanThe onecollector sealedmust plasticinspect bagthe canspecimen befor placedunusual intocolor, apresence singleof shippingforeign containerobjects ifor youmaterial, areor doingother multiplesigns collections.)of
(ii)Seal the container as appropriatetampering.
(iii)ait laboratoryis courierapparent hand-deliversfrom thethis specimensinspection fromthat the collectionemployee sitehas totampered with the laboratoryspecimen, prepare the sealedcollector plasticmust bagconduct fora shipmentnew as directed by the courier servicecollection.
(9i) SendDocument Copyany 2unusual ofcharacteristics thereferenced CCFabove toin the MRORemarks andsection Copyof 4 to the DERCCF.
(ii) YouProceed mustwith faxobtaining orthe otherwisenew transmitoral thesefluid copiesspecimen tofrom the MROdonor. andNote DERon withinthe 24new hoursCCF orthat duringthis theis nextanother businesscollection day.for Keepthe Copysame 3testing forevent at(i.e., leastDocument 30in days,the unlessremarks otherwisesection specifiedthat bythis applicableis DOTSpecimen agency2 regulations.of
(b)As2 aand collectorinclude orthe collectionSpecimen site,ID younumber mustof ensurethe thatother each specimen). youMake collectthe issame shippednotation toon athe laboratoryCCF asof quicklythe assuspect possible,specimen.
[88 butFR in27642, anyMay case2, within2023, 24as hoursamended orat during89 theFR next87798, business dayNov. 5, 2024]
(a) The collector must be present and maintain visual contact with the employee during the procedures outlined in this section.
(1) As the oral fluid collector, you must not allow any person other than you, the employee, or a DOT agency representative to actually witness the testing process.
(2) [Reserved]
(b) The collector must note any unusual behavior or appearance of the employee on the CCF. If the collector detects any conduct that clearly indicates an attempt to tamper with a specimen (e.g., an attempt to bring into the collection site an adulterant or oral fluid substitute), the collector must terminate the collection and report the information to the DER so that the employer can decide whether to deem the situation a refusal.
(c) The employee and collector must complete the specimen collection in accordance with the manufacturer's instructions for the collection device.
(1) Under the observation of the collector, the employee is responsible for positioning the specimen collection device for collection.
(2) The collector must ensure the collection is performed correctly (i.e., using the oral fluid device in the manner described by its manufacturer), that the collection device is working properly, and that a sufficient specimen volume is collected. After the employee provides a sufficient specimen, check the “Volume Indicator(s) Observed” box in Step 2 of the Federal CCF to document that you observed the volume indicator(s) during the collection.
(3) If the employee states that he or she is unable to provide an oral fluid specimen or provides an insufficient specimen during the collection process, the collector must continue to make one attempt to collect, after an insufficient specimen, the collector follows the procedure in § 40.193.
(4) The collector must inspect the specimen for unusual color, presence of foreign objects or material, or other signs of tampering. If it is apparent from this inspection that the employee has tampered with the specimen, the collector must conduct a new collection.
(i) Document any unusual characteristics referenced above in the Remarks section of the CCF.
(ii) Proceed with obtaining the new oral fluid specimen from the donor. Note on the new CCF that this is another collection for the same testing event (i.e., Document in the remarks section that this is Specimen 2 of 2 and include the Specimen ID number of the other specimen). Make the same notation on the CCF of the suspect specimen.
[88 FR 27642, May 2, 2023, as amended at 89 FR 87798, Nov. 5, 2024]
Amendment history
9 distinct wordings on file since Oct. 1, 2001- [88 FR 27642, May 2, 2023, as amended at 89 FR 87798, Nov. 5, 2024]
- [88 FR 27642, May 2, 2023]
- [88 FR 27642, May 2, 2023]
- [88 FR 27642, May 2, 2023]
- [88 FR 27642, May 2, 2023]
- [65 FR 79526, Dec. 19, 2000, as amended at 71 FR 49384, Aug. 23, 2006; 80 FR 19553, Apr. 13, 2015]
- [65 FR 79526, Dec. 19, 2000, as amended at 71 FR 49384, Aug. 23, 2006; 80 FR 19553, Apr. 13, 2015]
- [65 FR 79526, Dec. 19, 2000, as amended at 71 FR 49384, Aug. 23, 2006]
- Oct. 1, 2001 → Oct. 1, 2006annual editions 2001–2005
A new entry appears whenever the regulatory words change between government snapshots. Day-precise from the eCFR (2017 onward); before that, one snapshot per annual CFR edition (revised as of October 1). Bracketed citations are the Federal Register history printed with the section. Set a case date in the header to read any earlier wording.