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Chapter Law Content

Chapter 4 File and Archive Management
Article 16
Upon receipt of specimen, the laboratory shall conduct tests in accordance with the items designated by the test consignor as soon as possible, and produce a test report. The results of initial test or confirmatory test shall first be confirmed by the certifying scientist, and the test report shall be subscribed or signed by the responsible person.
A test report shall at least include the serial number of urine specimen, the cutoff values of drugs and the drugs detected or not detected, and shall remark the test method employed, the limit of quantification, and other data.
Article 17
The testing laboratories shall work out file control procedures to normalize the formulation, amendment, periodical examination, distribution, control, archiving and storage of the related files. The files and records relating to test shall be stored for at least two years or disposed in accordance with the Archives Act, and the storage period may be prolonged according to the request of the test consignor.
Article 18
The testing laboratories shall establish relevant archives, at least including personnel data, log sheet for specimen management, quality manual, quality management and quality assurance records, all original test data, test report, inspection and performance test reports, and data printed by computer, and store them appropriately.
Article 19
Every month the testing laboratories shall, before the tenth day of the next month, summarize the results of urine tests in specified format and submit to the Food and Drug Administration, Ministry of Health and Welfare for reference.