Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical Institutions Article 12

The applicant testing institution, within six months after passing the preliminary document review of Paragraph 3 of the preceding Article, shall complete three times of performance test and the inspection conducted by the executive institution on the drugs or metabolites of Paragraph 1 Subparagraph 5 of the preceding Article.Performance test shall include negative urine specimen, positive urine specimen mixed with the drug to be tested of a known concentration, and positive urine specimen with a concentration near to the cutoff value of the drug to be tested or its metabolite.The accuracy of performance test shall reach 90% or above, and false positive result may not occur. For 80% or more of the results, the difference between the measured value of the drug to be tested and the value nominated by the executive institution shall be within 20% or two standard deviations, and in no case the difference may be 50% or more.Where the performance test fails to satisfy the requirements in the preceding Paragraph, three times of performance test shall be conducted after the defects are corrected.Inspection shall be conducted in accordance with the relevant regulations of the drug abuse urine testing institutions. Where an applicant testing institution fails to pass the inspection, another inspection shall be performed additionally after the defects are corrected.