Regulations and Guidelines

Globally, various guidelines for substance abuse management have been developed by government agencies, forensic societies, and clinical organizations. Some of the guidelines include more detailed technical and procedural recommendations for specimen collection and processing, initial drug screening, confirmation analysis, quality control and assurance, and documentation and result-reporting requirements.

In the United States, the federally regulated drug-testing programs are implemented and administered by the Substance Abuse and Mental Health Services Administration (SAMHSA, formerly National Institute of Drug Abuse) and Department of Health and Human Services. The 1994 SAMHSA Mandatory Guidelines for Federal Workplace Drug Testing Programs (90) define initial test or screening test as "an immunoassay test to eliminate negative urine specimens from further consideration and to identify the presumptively positive specimens that require confirmation or further testing." The guidelines mandate that the initial test "shall use an immunoassay which meets the requirements of the Food and Drug Administration (FDA) for commercial distribution." The guidelines also permit multiple initial tests (or rescreening) to be performed utilizing different immunoassays for the same drug or drug class under the stipulation that "all tests meet all Guideline cutoffs and quality control requirements."

The regulated approach to initial screening "permits rapid identification of presumptive positives within a framework of extensive quality control and offers a defined reference if the next step confirmation is required." This allows a process with a set "administrative cutoff" for uniform comparison across different assay principles and various volumes of screening. The specified cutoff levels for cannabinoids testing were set at 100 ng/mL for immunoassays and 15 ng/mL for GC/MS in the first Mandatory Guidelines (53 FR 11970, 1988). The cutoff for immunoassay was lowered to 50 ng/mL in the subsequent version of the federal guidelines (91). In case a retest is required for a specimen or for the testing of Bottle B of a split specimen, the federal guidelines state that the retest quantification is not subject to a cutoff requirement. However, the retest "must provide data sufficient to confirm the presence of the drug or metabolite" (90).

The proposed revisions for the next version of the Mandatory Guidelines (91,92) will include regulations on specimen validity testing, POCT, and alternative specimen testing. Additionally, the new guidelines will expand the authorized confirmation method from only GC/MS to allow the use of additional confirmation technologies such as LC/MS. However, the new guidelines draft does not change the cutoff requirements for cannabinoid testing. Other civilian drug-testing programs, such as the College of American Pathologists Forensic Urine Drug Testing laboratory accreditation program, allow the cutoff determinations be made according to the need of the laboratory or to the intent of its clients' drug-testing programs. Generally speaking, even in nonregulated sectors, many drug-testing programs follow the cutoff defined by the federal guidelines and require reporting positive results if both the initial immunoassay results and the GC/MS analysis are at or above their respective cutoff concentration.

The provisions of the rules that affect US corporations may be imposed on their global employees. In contrast, countries in the European Union, Asia, and Australia differ in their concerns and strategies in relation to substance abuse problems. Surveys of DAT in European Union laboratories in the late 1990s indicated that a high percentage of laboratories did not use or report cutoff (93-95). A few work groups in Europe have proposed consensus or country-specific guidelines and cutoffs, including drug-testing application-specific cutoffs, for DAT (see, e.g., refs. 96-98). The European Laboratory Guidelines for Legally Defensible Workplace Drug Testing were developed by the European Workplace Drug Testing Society with an aim to "establish best practice" for laboratories within Europe "whilst allowing individual countries to operate within the requirements of national customs and legislation" (98). For urine drug testing, the maximum cutoff for screening test and the confirmation cutoff recommended by the European Workplace Drug Testing Society for cannabis metabolites are the same as those mandated by the current SAMHSA guidelines.

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