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Quality control programme for the analysis of drugs of abuse in urine

The Quality control programme for the analysis of drugs of abuse in urine (PCQ) has been ongoing interruptedly since 1986. It is an external quality control programme with a highly emphasized educational component.

The Coordinating Laboratory is the Analytical Services Laboratory for the Neurosciences programme's Bioanalysis and Analytical Services research group at the IMIM (Hospital del Mar Medical Research Institute) in Barcelona. Since November of 2000, the Coordinating Laboratory has been recognized as an Assay laboratory accredited by ENAC (National Entity for Accreditations) following the accrediting criteria stated in Regulation EN 45001 and ISO Guide 25. Since March of 2002, the Laboratory has been accredited as an Assay Laboratory according to ISO 17025 for the analysis of drugs of abuse and medications in biological fluids, including the use of eight quantitative procedures for the analysis of drugs of abuse in urine. The PCQ works under the requirements of the ISO 43 Guide (Proficiency testing by interlaboratory comparisons).

Laboratories participating in the PCQ are grouped into two categories depending on the type of analyses they perform (screening qualitative analyses and specific identification of substances and quantitative analyses) and thus the type of results they provide.

• Laboratories performing screening analyses for groups of substances in control urine samples. In general, they use immunological analytical methods.
• Laboratories performing, in addition to the screening analyses, identification and in some instances quantification of substances present in control urine samples.

This distinction between laboratories based on the type of analyses they perform is similar to that made between purely clinical and medical-legal laboratories; these two types of laboratories have different requirements in regards to the quality of the results they must provide. Thus two modalities of participation in the PQC are offered so that participating laboratories may choose the option that best meets their individual needs.

• Participation in the PCQ implies costs that are absorbed by participating laboratories. Registration as a participant in the PCQ offers the following benefits and services:
• Regular shipments of control urine samples to be analyzed by the participating laboratory. These urine samples may contain reference substances or may be urines of patients or may come from subjects in excretion studies done with healthy volunteers in a controlled trial. All urine samples are in a liquid state and have been submitted to a sterilization process.
• Creation of reports including quantitative and qualitative results.
• Supplying of reference materials (Laboratories included in Group II) for the standardization of analytical techniques.
• Training and consulting in immunological and chromatographical techniques for the analysis of drugs of abuse in urine.