§ 40.73 How is an oral fluid specimen collected?
Wording effective June 1, 2023, superseded June 21, 2024.
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(ab) AsThe the collector, whenmust usingnote theany paperunusual CCF,behavior youor mustappearance doof the followingemployee thingson to complete the collection processCCF. YouIf must complete the stepscollector calleddetects forany inconduct paragraphsthat (a)(1)clearly throughindicates (7)an ofattempt thisto sectiontamper inwith thea employee'sspecimen presence.(1)e.g., Directan theattempt employee to readbring andinto sign the certificationcollection statementsite onan Copyadulterant 2or (Steporal 5fluid substitute), of the CCFcollector andmust provideterminate datethe ofcollection birth, printed name, and dayreport and evening contact telephone numbers. If the employeeinformation refuses to sign the CCFDER orso tothat providethe dateemployer ofcan birth,decide printedwhether name,to ordeem telephone numbers, you must note this in the “Remarks”situation linea refusal.
(Step 2c) ofThe theemployee CCF, and completecollector themust collection.complete If the employeespecimen refusescollection toin fillaccordance outwith any information, you must, as a minimum, print the employeemanufacturer's nameinstructions infor the appropriatecollection placedevice.
(21) CompleteUnder the chainobservation of custody on the CCF (Step 4) by printing your name (note: you may pre-print your name)collector, recording the timeemployee andis dateresponsible offor thepositioning collection, signing the statement, and entering the name 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.
(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 or otherwise transmit these copies to the MROnew andoral DERfluid withinspecimen 24from hours or during the next business daydonor. KeepNote Copyon 3the fornew atCCF leastthat 30this days,is unlessanother otherwisecollection specifiedfor bythe applicablesame DOTtesting agencyevent regulations.(b) As a collectori.e., whenDocument usingin other forms of the CCFremarks assection approvedthat bythis theis OfficeSpecimen 2 of Management2 and Budget,include you must follow the proceduresSpecimen approvedID fornumber thatof form.the
(c)Asother a collector or collection site, you must ensure that each specimen). youMake collectthe issame shippednotation toon athe laboratoryCCF asof quickly as possible, but in any case, within 24 hours or during the nextsuspect business dayspecimen.
[6588 FR 7952627642, Dec.May 192, 2000, as amended at 71 FR 49384, Aug. 23, 2006; 80 FR 19553, Apr. 13, 20152023]
(a) The collector must be present and maintain visual contact with the employee during the procedures outlined in this section.
(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.
(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]
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.