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What does 49 CFR 40.175 (What steps does the first laboratory take with a split specimen?) require?

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According to 49 CFR 40.175, when the primary and split specimens first arrive at your laboratory, you must take the following steps:

* Check Availability: Check to see if the split specimen is available for testing.

* If the Split Specimen is Unavailable or Insufficient:

* Continue testing the primary specimen normally and report those results without including Medical Review Officer (MRO) information about the unavailable split specimen.

* If you receive a letter from the MRO instructing you to forward the split specimen to another laboratory, report back to the MRO that it is unavailable, providing as much detail as possible about why.

* Prohibition on Opening: You are not allowed to open the split specimen under any circumstances (unless it is redesignated under § 40.83).

* Forwarding to a Second Laboratory: When you receive written notice from the MRO to send the split specimen to another HHS-certified laboratory, you must forward:

1. The split specimen in its original bottle with the seal intact;

2. A copy of the MRO's written request; and

3. A copy of Copy 1 of the Custody and Control Form (CCF), showing the specific drugs, metabolites, or validity criteria to be tested.

* Protecting Employee Identity: Do not send any information identifying the employee to the second laboratory (though an accidental disclosure is not a fatal flaw).

§ 49 CFR 40.175 · eCFR ↗Sources retrieved: 1 retrieved CFR section

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