4 min
Maximum time to check specimen temperature after receiving it
45 mL
Minimum specimen volume required to proceed
30 mL
Minimum volume poured into Bottle A (primary specimen)
90—100°F
Acceptable temperature range for a valid specimen (32—38°C)
3 hrs
Maximum shy-bladder period. At 3 hours you discontinue and notify the DER — the outcome is decided later (§40.193(d))
40 oz
Fluid offered, distributed reasonably over up to 3 hours (§40.193(b)(1)(ii))
1
Note the actual temperature on the CCFCheck the "out of range" box and record the temperature reading in the remarks section.
2
Conduct a new collection under direct observationYou must immediately conduct a new collection. §40.65(b)(5) gives two routes: a new urine collection under direct observation (§40.67), or an oral fluid collection. Both specimens are then sent (§40.65(b)(6)). In practice the oral-fluid route is not yet available: DOT oral fluid testing requires two HHS-certified laboratories, and that condition has not been met, so directly observed urine is currently the operative route. §40.65(d) tells you who picks the method: follow the employer’s standing order on specimen type if there is one, and contact the DER if there is not — that decision comes before you select observed urine or oral fluid. What is not optional is acting immediately — the collector does not wait for or assess a medical explanation.
3
Send both specimens to the labThe original out-of-range specimen and the directly observed specimen are both sent. The MRO will determine how to handle the results.
4
Notify the DERReport the objective facts to the employer's Designated Employer Representative: the temperature was out of range, a second collection was conducted, and the reason for it. An out‑of‑range temperature triggers the procedure — it does not by itself establish that substitution or tampering occurred.
Do not discard the original specimen. Even if the temperature was out of range, both specimens go to the lab. That exception is specific. In the ordinary shy-bladder case you do discard the insufficient specimen (§40.193(b)(1)(i)), and at the end of the three-hour period you must discard any specimen previously provided (§40.193(b)(1)(iv)). Discarding is scenario-dependent, not never.
- Donor fails to appear at the collection site
- Donor leaves the site before the collection is complete
- Donor refuses to empty pockets or remove outer garments when directed
- Donor admits to adulterating or substituting the specimen
- Donor behaves in a way that clearly indicates intent to tamper with the specimen
- MRO-directed medical evaluation refused by donor
Declining to sign the CCF is NOT a refusal. §40.79(a)(1): if the donor declines to sign the Step 5 certification or to provide required information, note it on the “Remarks” line (Step 2) and complete the collection. At minimum, print the donor’s name yourself. Do not terminate the collection and do not report it as a refusal.
Watch the specimen type — the rule is the opposite on the alcohol side. Refusing to sign the certification at Step 2 of the ATF is a refusal (§40.261(a)(6), §§40.241(g), 40.251(d)). CCF = drug = not a refusal. ATF = alcohol = refusal.
Do not try to talk the donor into complying. Branch by specimen type — “possible refusal” does not mean “terminate” on the urine side.
URINE. Clear tampering conduct you observe during the collection does not end the collection: §40.63(e) requires a collection to take place immediately under direct observation, the conduct noted in Remarks, the “Observed” box checked, and the DER and collection site supervisor informed. An out-of-range temperature (§40.65(b)(5)) or a specimen showing signs of tampering (§40.65(c)(1)) likewise requires an immediate new collection, not termination. You terminate only when the employee actually refuses the required participation or the recollection — then note it, notify the DER, and let the employer decide (§40.191(a)(4), §40.65(b)(7), §40.65(c)(3)).
ORAL FLUID. The rule is different: under §40.72(a)(3), where materials brought to the site or the employee’s conduct clearly indicate an attempt to adulterate, substitute or alter, the collector must terminate the collection, note the circumstances in Remarks and report to the DER, so the employer can decide whether it is a refusal.
In every case the determination itself is the employer’s — you document and report, you do not decide. Do not attempt to persuade or argue with the donor. Your job is to document accurately — not to negotiate, and not to make the refusal determination.