National Laboratory Certification Program
The Substance Abuse and Mental Health Services Administration (SAMHSA) within HHS establishes the scientific and technical guidelines to be used by US federal agencies and drug-testing laboratories for federally regulated drug testing. Testing must be performed at laboratories accredited by HHS under the National Laboratory Certification Program (NLCP). HHS has maintained oversight of federally regulated drug testing through this laboratory accreditation program since it began in 1988. By January 1989, the first 10 laboratories had been accredited by HHS (figure 16.2). The number of certified laboratories rose to 92 in 1993 and 1994, and has dropped to 42 in January 200B.
Laboratories which are accredited under this program perform an estimated 7 million federally regulated drug tests per year. The current version of the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs was published in April of 2004. HHS has proposed additional revisions to the Guidelines, which are under government review at the time of this writing. The NLCP laboratory accreditation program is designed to verify that participant laboratories are in compliance with the requirements of the HHS Mandatory Guidelines and with good forensic laboratory practice.
Program process include an application process, onsite inspections, (that is, an initial qualification inspection and biannual certification maintenance inspections), and a performance testing (PT) program consisting of initial qualification PT cycles and quarterly certification maintenance PT cycles. In addition, the NLCP provides for verification of key laboratory stabs qualifications and ongoing review of their job performance related to federally regulated drug testing. Laboratories are required to take remedial actions to address deficiencies identified through the NLCP inspection and PI processes, as well as problems reported to HHS by third parties such as other federal agencies, employers, and MROs.
College of American Pathologists
The College of American Pathologists (CAP) is a medical society whose members are board-certified pathologists. CAP’s laboratory accreditation programs include a general program for clinical laboratories, a program for reproductive laboratories, and a forensic urine drug-testing (FUDT) program for laboratories performing testing for nonmedical purposes, including workplace drug testing. Begun in 1989, the CAP FUDT program is based on CAP Standards for Accreditation for laboratories performing forensic testing. These consist of 4 standards addressing (1) qualifications, responsibilities, and the role of the laboratory’s scientific director; (2) resources and facilities; (3) quality assurance and quality control; and (4) inspection requirements.
Under the CAP FUDT accreditation program, laboratories are accredited for 2 years. Each accredited laboratory undergoes an onsite inspection every 2 years and must perform a self-assessment between inspections (i.e., at the 1-year mark). Laboratories must also participate in the quarterly CAP proficiency testing survey for drugs of abuse or in a CAP-approved alternative proficiency testing program. Laboratories are required to take corrective action to address identified deficiencies.
International Organization for Standardization
The International Organization for Standardization (ISO) is a non-governmental organization that, with its partner the International Electro-technical Commission (EC), develops and publishes international standards. ISO’s goal is for these standards to serve as a reference framework and to provide common technological language for suppliers and their customers, and to facilitate trade and the transfer of technology internationally. At the time of this writing, ISO has 157 member countries and offers more than 16,500 International Standards and other types of ISO normative documents. ISO accreditation is an option for workplace drug-testing laboratories wishing to demonstrate their competence by formal compliance with a set of internationally recognized criteria.
In the ISO system, standards are developed by technical committees made up of experts from relevant industrial, technical, and business sectors, as well as representatives of government agencies, testing laboratories, consumer associations, non-governmental organizations, and academia. The technical committee develops a standard that provides specifications and criteria to be applied consistently in the classification of materials, in the manufacture and supply of products, in testing and analysis, in terminology, and in the provision of services.
The ISO/IEC standard that is applicable to workplace testing laboratory ties is ISO/IEC 17025, General requirements for the competence of testing and calibration of laboratories. This standard is applicable to a wide range of testing and calibration laboratories, and provides general requirements related to laboratory management and administration, as well as technical requirements. Relevant quality management principles of another well-known ISO standard, ISO/IEC 9001, have been incorporated into ISO/ IEC 17025. A laboratory accredited to ISO/IEC 17025 is demonstrating compliance with these established laboratory and quality management standards. International cooperatives, technical organizations, and laboratory accreditation bodies may develop supplemental manuals and guides for use in applying the general ISO/IEC 17025 standards to workplace drug-testing laboratories. At the time of this writing, there are supplemental manuals and guides for forensic laboratories that may be useful for laboratories performing workplace drug testing.
Another international standard that may be of interest to workplace drug-testing laboratories is ISO/IEC 17011, Conformity assessments general requirements for accreditation bodies accrediting conformity assessment bodies. This standard specifies general requirements for the assessment of accreditation bodies (i.e., the independent third parties) that, in turn, assess and accredit laboratories. National, regional, and international organizations who grant recognition to accreditation bodies may use ISO/IEC 17011, along with sector-specific technical criteria, to evaluate the competence of an accreditation body. When selecting an accreditation body, laboratories should verify the accreditation body’s qualifications and ensure that it has been evaluated and recognized as compliant with relevant standards and criteria