Ask X3What does 49 CFR 40.83 (How do laboratories process incoming specimens?) require?
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As Ask X3, your fleet-compliance assistant, here is what 49 CFR 40.83 requires laboratories to do when processing incoming DOT specimens:
* Authorized CCF Copies: You are authorized to receive only Copy 1 of the Custody and Control Form (CCF). You must not receive other copies of the CCF or any alcohol testing form copies.
* HHS Guidelines: You must comply with applicable HHS Guidelines on accessioning and processing drug specimens.
* Inspection for Fatal Flaws: You must inspect each specimen and CCF for specific "fatal flaws," which include:
* No CCF provided.
* A specimen was collected, but no specimen was submitted with the CCF.
* No printed collector's name and no collector's signature.
* Two separate collections performed using a single CCF.
* Specimen ID numbers on the bottle and CCF do not match.
* The specimen bottle seal is broken or shows tampering (unless the split specimen can be redesignated).
* Insufficient specimen amount in the primary bottle for analysis (unless redesignated).
* For an oral fluid collection, an expired device was used.
* For an oral fluid collection, the collector failed to enter the expiration date in Step 4 of the CCF, and the laboratory cannot determine it by inspecting Bottles A and B.
* Handling Fatal Flaws: If a fatal flaw is found, document your findings, stop the testing process, and report the result in accordance with § 40.97(b)(3).
* Missing Collector Signature: If the collector's signature is missing from the certification statement in Step 4 of the CCF, document the flaw, continue testing, retain the specimen for at least 5 business days from when correction action was initiated, attempt to correct it using § 40.205(b)(1), and reject/report the test if it remains uncorrected.
* Unchecked Temperature: If a urine specimen temperature was not checked and the "Remarks" line has no entry about it being out of range, attempt to correct it under § 40.208 for five business days before reporting the result.
* Improper Forms: If an improper form was used (such as a non-Federal or expired Federal form), attempt to correct it under § 40.205(b)(2), retain the specimen for at least 5 business days, and reject the test if not corrected.
* Split Specimen Issues & Redesignation: If the split specimen does not accompany the primary, has leaked, or is unavailable, you must still test the primary specimen following § 40.175(b). You may redesignate primary and split specimens (swapping Bottle A and B roles by marking, initialing, and dating the bottles) under specific conditions, such as a leaked primary bottle, labeling mix-ups, the laboratory opening the split bottle instead of the primary, or a broken primary seal, provided sufficient specimen exists.
* Documentation of Flaws: Make a notation on Copy 1 of the CCF (Step 5a) and internal chain of custody documents for any fatal or correctable flaw.
*(Reference: 49 CFR 40.83)*