BioTechScreening Blog: Laboratory Certifications for Drug Testing

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Sunday, August 26, 2012

Laboratory Certifications for Drug Testing

        LABORATORY CERTIFICATIONS
       From Norchem Laboratory

Urinalysis drug-testing conducted under the authority of the Court should require or mandate a high “Forensic Standard” that will insure the accuracy and “Legal Defensibility” of those test results. This “Forensic Standard” is directly aligned with the level of “Certification” of the laboratory conducting the urinalysis testing. The following details the historic development of the three (3) major “Certification Programs” for drug testing laboratories.

SAMHSA (Substance Abuse and Mental Health Services Administration (NIDA), Final Guidelines, F.R./Vol 53. No. 69/April 11, 1988)
SAMHSA was created in response to demands for scientific and technical standards for Federal Workplace Drug Testing Programs and for the certification of laboratories engaged in urine drug testing for federal agencies. SAMHSA is distinguished from CLIA by its strict emphasis on “Legal Defensibility” and by its deliberately restricted regulatory scope; it is limited to urine testing for five drug classes. The SAMHSA Guidelines that insure “Legal Defensibility” include: 1) rigorous chain-of-custody for the collection, testing, and storage of the specimens, 2) strict laboratory security with restricted laboratory access and locked specimen storage, 3) precise requirements for quality assurance, 4) performance testing specific to urine assays for five drug classes, 5) specific educational requirements for laboratory personnel to insure their credibility as Forensic Drug Testing Experts. The SAMHSA Guidelines make it clear that they do not apply to drug testing performed under any legal authority other than the Mandatory Federal Workplace Drug Testing

CAP-FUDT - 1988 (College of American Pathologists/Forensic Urine Drug Testing)The gap left between CLIA and SAMHSA made the development of a separate laboratory certification program essential to insure the protection of individual rights and the “Legal Defensibility” of forensic urine drug testing outside the limited context of federal programs. In 1988 CAP, in consultation with the American Association for Clinical Chemistry, developed the FUDT accreditation program designed specifically for non-federal workplace drug testing. It was modeled after the SAMHSA program and includes the five items above to insure “Legal Defensibility” but the scope of the program was expanded to cover any drug test performed on urine. The objective of the CAP-FUDT program is to improve the quality of laboratory services so that all testing is performed in a scientific and “Legally Defensible” manner. The CAP-FUDT program emphasizes the importance of confirmatory tests to meet forensic requirements.

CLIA – 1988 (Clinical Laboratory Improvement Act of 1988)
CLIA was enacted to insure that all laboratories provide accurate results for medical diagnosis and treatment decisions. CLIA has applied a single set of requirements that apply to almost all laboratory testing of human specimens. CLIA also established enforcement procedures and sanctions applicable when laboratories fail to meet standards. Compared to most clinical tests, the legal consequences of a positive urine drug test may be severe and present a heightened probability of a legal challenge. Therefore, drug tests are considered “Forensic Testing”. However, the CLIA laboratory certification program does not provide for chain-of-custody procedures and documentation, quality assurance and performance testing specific to forensic urine drug testing (FUDT) such as confirmation procedures. Additionally, CLIA does not specifically have trained inspectors to perform on-site evaluation of forensic laboratories.

Labels: clia, fda, justice, laboratory, testing, urine, workplace

by: BioTechScreening

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