§ 40.73 How is an oral fluid specimen collected?
Current wording, effective December 5, 2024.
(a) AsThe the collector, whenmust usingbe thepresent paperand CCF,maintain youvisual mustcontact dowith the followingemployee thingsduring to complete the collectionprocedures process.outlined Youin mustthis completesection.
(1) As the stepsoral calledfluid forcollector, inyou paragraphsmust (a)(1)not throughallow (7)any ofperson thisother sectionthan inyou, the employee's, presence.or
(1)Directa theDOT employeeagency representative to readactually andwitness sign the certificationtesting statement on Copy process.
(2) [Reserved]
(Step 5b) 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), of the CCF,collector andmust completeterminate the collection. Ifand report the employeeinformation refuses to fillthe outDER anyso information,that youthe must,employer ascan adecide minimum,whether printto thedeem employee's name in the appropriatesituation placea refusal.
(2c) CompleteThe theemployee chainand ofcollector custodymust oncomplete the CCFspecimen (Stepcollection 4)in byaccordance printingwith yourthe namemanufacturer's (note:instructions youfor maythe pre-printcollection your namedevice.
(1), recordingUnder the timeobservation and date of the collectioncollector, signing the statement,employee andis enteringresponsible thefor namepositioning of the delivery service transferring the specimen tocollection thedevice laboratory,for collection.
(32) EnsureThe thatcollector allmust copiesensure of the CCFcollection areis legibleperformed andcorrectly complete.(4)i.e., Removeusing Copy 5 of the CCForal andfluid givedevice itin to the employee.manner
(5)Placedescribed theby specimenits bottlesmanufacturer), andthat Copy 1 of the CCFcollection indevice theis appropriateworking pouchesproperly, ofand thethat plastica bag.sufficient
(6)Securespecimen bothvolume pouchesis of the plastic bagcollected.
(7)AdviseAfter the employee thatprovides hea orsufficient shespecimen, maycheck leave the collection“Volume site.Indicator(8s) ToObserved” preparebox thein sealedStep plastic2 bagof containing the specimensFederal and CCF forto shipmentdocument that you must:observed
(i)Place the sealedvolume plastic bag in a shipping container indicator(e.g., standard courier boxs) designedduring to minimize the possibility of damage during shipmentcollection.
(More3) thanIf onethe sealedemployee plasticstates bagthat canhe beor placedshe intois aunable singleto shippingprovide containeran iforal youfluid arespecimen doingor multipleprovides collections.)an
(ii)Sealinsufficient thespecimen containerduring asthe appropriate.collection
(iii)Ifprocess, athe laboratorycollector couriermust hand-deliverscontinue theto specimensmake fromone theattempt collection site to the laboratorycollect, prepareafter thean sealedinsufficient plasticspecimen, bagthe forcollector shipmentfollows asthe directedprocedure byin the§ courier service40.193.
(94) SendThe Copycollector 2must ofinspect the CCFspecimen tofor theunusual MROcolor, andpresence Copyof 4foreign toobjects theor DER.material, Youor mustother faxsigns orof otherwisetampering. transmitIf theseit copiesis toapparent thefrom MROthis andinspection DERthat withinthe 24employee hourshas ortampered duringwith the nextspecimen, businessthe day.collector Keepmust Copyconduct 3a fornew atcollection.
(i) leastDocument 30any days,unusual unlesscharacteristics otherwisereferenced specifiedabove byin applicablethe DOTRemarks agencysection regulationsof the CCF.
(bii) AsProceed awith collector,obtaining whenthe usingnew otheroral formsfluid ofspecimen from the CCFdonor. asNote approvedon by the Officenew ofCCF Managementthat andthis Budget,is youanother mustcollection followfor the proceduressame approvedtesting forevent that form.(c)i.e., AsDocument ain collectorthe orremarks collectionsection site,that youthis mustis ensureSpecimen that2 eachof specimen2 youand collectinclude isthe shippedSpecimen toID anumber laboratoryof asthe quicklyother asspecimen). possible,Make butthe insame anynotation case,on withinthe 24CCF hoursof or during the nextsuspect business dayspecimen.
[6588 FR 7952627642, Dec.May 192, 20002023, as amended at 7189 FR 4938487798, AugNov. 235, 2006; 80 FR 19553, Apr. 13, 20152024]
(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.