§ 40.101 What relationship may a laboratory have with an MRO?
Current wording, in the annual edition revised as of Oct. 1, 2001.
(a) TheAs stepsa for preparation for testing shall be the same as provided for breath alcohol testing in § 40.61 of this part.laboratory,
(b) The STT shall complete Step 1 on the form required by § 40.99. The employee shall then complete Step 2 on the formsigningyou themay certification.not Refusalenter byinto theany employeerelationship towith signan thisMRO certificationthat shallcreates be regarded as a refusalconflict toof takeinterest theor test.the
(c) If employerappearance isof using a non-evidentialconflict breathof testinginterest device,with the STTMRO's shallresponsibilities follow the same steps outlined for screening tests using EBTs in § 40.63.the employer
(d) If is using a saliva testing device, the STT shall take the following steps:.
(1) The STT shall explain the testing procedure to the employee
(2)TheYou STTmay shall check the expiration date of the saliva testing device, show the date to the employee, and shall not usederive a device at any timefinancial subsequentbenefit toby thehaving expiration date.an
(3) The STT shall open individuallyemployer sealeduse packagea containingspecific the device in the presence of the employeeMRO.
(4b) The STTfollowing shallare offerexamples the employee the opportunity to use the swab. If the employee chooses to use the swab, the STT shall instruct the employee to insert the absorbent end of therelationships swabbetween intolaboratories theand employee'sMROs mouth,that moving it actively throughout the mouthDepartment forregards a sufficient time to ensure that it is completely saturated, as providedcreating inconflicts theof manufacturer's instructions for the device.interest, or
(5) If the employee chooses not to use the swabin all cases in which a new test is necessary because the deviceappearance did not activate (see paragraph (d)(8) of thissuch section),conflicts. theThis STTfollowing shalllist insert the absorbent end of theexamples swabis intonot theintended employee's mouth, moving it actively throughout the mouth for a sufficient time to ensurebe thatexclusive itor is completely saturated, as provided in the manufacturer's instructions for the device. The STT shall wear a surgical grade glove while doing so.exhaustive:
(61) The STTlaboratory shallemploys placean theMRO devicewho onreviews atest flatresults surfaceproduced orby otherwise in a position in which the swab can be firmly placed into the opening provided in the device for this purpose. The STT shall insert the swab into this opening and maintain firm pressure on the device until the device indicates that it is activated.laboratory;
(72) If the procedures of paragraph (d)(3)-(d)(5) of this section are not followed successfully (e.g., the swab breaks, the STT drops the swab on the floor or another surface, the swab is removed or falls from the device before the device is activated), the STT shall discard the device and swab and conduct a new test using a new device. The newlaboratory device shall be one that has beena undercontract the control of the employer or STTretainer priorwith to the test.MRO The STT shall note in the remarks section of the form the reason for the newreview test. In this case, the STT shall offer the employee the choice of using the swab himself or herself or having the STT use the swab. If the procedures of paragraph (d)(3)-(d)(5) of this section are not followed successfully on the new test, theresults collectionproduced shallby be terminated and an explanation provided in the remarks section of the form. A new test shall then be conducted, using an EBT for both the screening and confirmation tests.laboratory;
(8) If the procedures of paragraph (d)(3)-(d)(5) ofThe thislaboratory sectiondesignates arewhich followedMRO successfully, but the deviceemployer is notto activateduse, thegives STT shall discard the deviceemployer and swab and conduct a newslate test, in the same manner as provided in paragraph (d)(7) of thisMROs section.from Inwhich thisto casechoose, theor STTrecommends shallcertain place the swab into the employee's mouth to collect saliva for the new test.MROs;
(94) The STTlaboratory shallgives read the resultemployer displayeda ondiscount theor deviceother twoincentive minutes after inserting the swab into the device. The STT shall show the device and its reading to theuse employeea andparticular enter the result on the form.MRO;
(105) Devices,The swabs,laboratory gloveshas andits otherplace materials used in saliva testing shall not be reused, and shall be disposed of inbusiness aco-located sanitary manner following their use, consistent with applicablethat requirements.of
(e) In the case anyan screeningMRO testor performedMRO understaff thiswho section,review thetest STT,results afterproduced determiningby the alcohollaboratory; concentration result, shall follow the applicable provisions of § 40.63 or
(e6)(1)-(2), (f), (g), and (h). The STTlaboratory shallpermits alsoan enterMRO, inor thean “Remarks”MRO's section of the formorganization, ato notationhave that the screening test was performed using a non-evidentialfinancial breathinterest testing device or a saliva device, as applicable. Following completion of the screening test, the STT shall date the form and sign the certification in Step 3 of the formlaboratory.
(a) As a laboratory, you may not enter into any relationship with an MRO that creates a conflict of interest or the appearance of a conflict of interest with the MRO's responsibilities for the employer. You may not derive any financial benefit by having an employer use a specific MRO.
(b) The following are examples of relationships between laboratories and MROs that the Department regards as creating conflicts of interest, or the appearance of such conflicts. This following list of examples is not intended to be exclusive or exhaustive:
(1) The laboratory employs an MRO who reviews test results produced by the laboratory;
(2) The laboratory has a contract or retainer with the MRO for the review of test results produced by the laboratory;
(3) The laboratory designates which MRO the employer is to use, gives the employer a slate of MROs from which to choose, or recommends certain MROs;
(4) The laboratory gives the employer a discount or other incentive to use a particular MRO;
(5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory; or
(6) The laboratory permits an MRO, or an MRO's organization, to have a financial interest in the laboratory.
Amendment history
2 distinct wordings on file since Oct. 1, 1996- Oct. 1, 1996 → Oct. 1, 2001annual editions 1996–2000
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.