Subpart F - W1 Drug Testing Laboratories

Target Language or Knowledge:

As a drug testing laboratory located in the U.S., you are permitted to participate in DOT drug testing only if you are certified by HHS under the _National_ _Laboratory_ Certification Program for all testing required.

8. Fill in the blank. You must inspect each CCF for the presence of the collector's signature on the certification statement in Step 4 of the CCF. Upon finding that the signature is omitted, document the flaw and continue the testing process. In such a case, you must retain the specimen for a _minimum_ of 5 business days from the date on which you initiated action to correct the flaw.

If you determine that the specimen temperature was not checked and the "Remarks" line did not contain an entry regarding the temperature being _outside_ of _range,_ you must then attempt to correct the problem by following the procedures.

If the CCF is marked indicating that a split specimen collection was collected and if the split specimen does not accompany the primary, has _leaked,_ or is otherwise unavailable for testing, you must still _test_ the primary specimen and follow appropriate procedures regarding the unavailability of the split specimen for testing.

For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the Immunoassay to the other analyte(s) within the group must be 80 percent or _greater;_ if not, separate must be used for the analytes within the group

When using alternate technology, initial test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the _initial_ and _confirmatory_ tests (i.e., 15 ng/mL for THCA and 100ng/mL for Benzoylecgonine).

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.

Specimen Validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine. The purpose is to determine whether certain _adulterants_ or _foreign_ substances were added to the urine, if the urine was diluted, or if the specimen was substituted.

As a laboratory, you must consider the primary specimen to be substituted when the _creatinine_ concentration is less than 2 mg/dL and the specific _gravity_ is less than or equal to 1.0010 or greater than or equal to 1.0200 on both the initial and confirmatory tests.

As a laboratory, you must use _Invalid_ _Test_ result criteria for the initial and confirmation testing as required by the HHS Mandatory Guidelines and provide the numerical value that supports the invalid result, where appropriate, such as pH.

Category 1 or _Negative_ Results is when you find a specimen to be negative or _Negative-dilute,_ with numerical values for creatinine and specific gravity.

Category 2: _Non-negative_ Results are _Positive,_ with drug(s)/metabolite(s) noted, with numerical values for the drug(s) or drug metabolite(s), _Positive-dilute,_ with drug(s)/metabolite(s) noted, with numerical values for the drug(s) or drug metabolite(s) and with numerical values for creatinine and specific gravity, Adulterated, with adulterant(s) noted, with confirmatory test values (when applicable), and with remark(s), Substituted, with confirmatory test values for creatinine and specific gravity; or Invalid result, with remark(s).

Category 3: _Rejected_ for _Testing_ is when the result is _rejected_ with remark(s).

You may release the laboratory results report only after _review_ and _approval_ by the certifying scientist. .

As a laboratory, you must report laboratory results directly, and only, to the _MRO_ at his or her place of _business._ You must not report results to or through the DER or a service agent (e.g., C/TPA).