The HHS-Certified Laboratories Experience

Before 2001, laboratories and investigators involved in the NLCP program shared their information relating to the identity and composition of products that were thought to be involved in attempts to subvert urine drug testing. A summary of this information is presented in Table 5.1.

In July 2001, the NLCP inspection process was revised to include a formal specimen records audit. Before each inspection, the certified laboratory submits a list of all federally regulated specimens that were reported as drug-positive, adulterated, invalid, substituted, or rejected during a specified Month period. Inspectors assigned to perform the records audit during the NLCP inspection review the data chain of custody records and reports for these specimens. In this way, the NLCP has focused attention on those specimens whose donors may be subject to adverse action based on their drug tests, including those specimens reported as adulterated, invalid, or substituted. Other inspection team members are assigned to review the laboratory’s procedures and observe practice for compliance with program requirements.

The revised NLCP inspection process has allowed HHS to review distribution and concentration information from each certified laboratory (e.g., the number of specimens reported as drug-positive, adulterated, invalid, or substituted based on specimen validity testing and the type of adulterants reported). These findings are presented in Figures 5.2 and 5.3. The histograms show the number of federally regulated specimens reported to me NLCP by HHS certified laboratories, by Non-negative category, in12-month time periods. This information also allows the analyses of SVT reporting before and after November 1, 2004, (the effective date of the revised HHS Guidelines requiring certified laboratories to perform speck men validity testing of federally regulated specimens).

These data show an increase in the number of specimens reported as invalid after the revised Guidelines went into effect. The main reason for this increase is that, for forensic and scientific supportability, the Guidelines revisions included requirements for laboratories to use a specific confirmatory test to identify a specific adulterant before reporting a specimen as adulterated with that compound. Some laboratories chose to report specimens as invalid based on initial test results for 2 separate aliquots rather than implementing new analytical methods and/or new instrumentation necessary to identify specific adulterants. This approach is acceptable under the Guides lines, which also require laboratories to notify the MRO before repelling specimens as invalid in most cases to discuss whether a specimen should be sent for additional or different testing at another certified laboratory.