§ 40.87 What validity tests must laboratories conduct on primary urine specimens?

(a) As a laboratory, when you mustconduct usevalidity thetesting cutoffunder concentrations§ displayed in the following table for initial and confirmatory drug tests40.86, Allyou cutoffmust concentrationsconduct areit expressed in nanogramsaccordance perwith milliliterthe (ng/mL).requirements Theof tablethis follows:section.
Initial(a) testYou analyte Initialmust testdetermine cutoffthe concentration Confirmatorycreatinine test analyte Confirmatory test cutoff concentration
Marijuana metabolites 50on ng/mL THCAeach 1
15primary ng/mLspecimen.
Cocaine metabolites 150You ng/mL Benzoylecgonine 100must ng/mL.
Opiatealso metabolites
Codeine/Morphine2
2000determine ng/mL Codeine 2000its ng/mL.
Morphine 2000specific ng/mL.
6-Acetylmorphine 10gravity ng/mL 6-Acetylmorphine 10if ng/mL.
Phencyclidine 25you ng/mL Phencyclidine 25find ng/mL.
Amphetamines3
AMP/MAMPthe 4
500creatinine ng/mL Amphetamine 250concentration ng/mL.
Methamphetamine5
250to ng/mL.
MDMAbe 6
500less ng/mL MDMA 250than ng/mL.
MDA7
25020 ngmg/mLdL.
MDEA8
250 ng/mL
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid (THCAb).
2 MorphineYou ismust determine the targetpH analyteof foreach codeine/morphineprimary testingspecimen.
3(c) EitherYou amust singleperform initialone test kit or multiplemore initialvalidity testtests kitsfor mayoxidizing beadulterants usedon provided the single test kit detects each targetprimary analyte independently at the specified cutoffspecimen.
4(d) MethamphetamineYou ismust theperform targetadditional analytevalidity fortests amphetamine/methamphetamineon testing.
5the Toprimary be reported positive for methamphetamine, a specimen mustwhen alsothe containfollowing amphetamineconditions atare a concentration equal to or greater than 100 ng/mL.observed:
6 Methylenedioxymethamphetamine (MDMA1).
7 MethylenedioxyamphetamineAbnormal (MDA).
8physical Methylenedioxyethylamphetamine (MDEA).characteristics;
(b2) OnReactions anor initialresponses drugcharacteristic test,of youan mustadulterant reportobtained aduring resultinitial belowor theconfirmatory cutoffdrug concentrationtests as negative(e.g., Ifnon-recovery theof resultinternal is at or above the cutoff concentrationstandards, youunusual must conduct a confirmation test.
(cresponse); On a confirmation drug test, you must report a result below the cutoff concentration as negative and a result at or above the cutoff concentration as confirmed positive.
(d3) YouPossible mustunidentified reportinterfering quantitativesubstance values for morphine or codeine at 15,000 ng/mL or aboveadulterant.
(e) OnIf ayou 6-AMdetermine confirmedthat positivethe result:
(1)specimen When a 6-AM confirmed positive result is reportedinvalid and morphineHHS forguidelines thatdirect specimenyou isto notcontact reported at or above the 2000 per ng/mL confirmed positive cutoffMRO, you must confercontact with the MRO to determine if there was confirmed morphine below 2000 ng/mL.
(2) If morphine was not confirmed below 2000 ng/mL, you and thetogether MROdecide mustif determine whether further testing is needed to quantify the amountprimary ofspecimen morphineby concentrationanother present.
(3)HHS Ifcertified youlaboratory findwould nobe detectableuseful morphinein atbeing LODable uponto further testing, you must report thata factpositive toor ODAPCadulterated immediatelytest result.
[65 FR 79526, Dec. 19, 2000, as amended at 7569 FR 4986264867, AugNov. 169, 20102004. Redesignated and amended at 88 FR 27643, May 2, 2023]