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Chapter Law Content

Chapter 2 Specimen Collection and Management
Article 4
The testing institutions shall prescribe the chain of custody procedures for specimen collection and management, from the collection of urine specimen, test, reply of test report, to the storage of urine specimen and disposal of residual specimen, and record the handler, date and purpose of each operation.
Article 5
Matters records in the custody and control form shall include, at least, the serial number of urine specimen, the name and ID No. of donor, the name and address of test consignor, the name and address of urine collecting institution, the name of collector, the time of urine collection, important and special evidences, as well as the time, purpose and operator of the collection, disposal, storage and withdrawal of specimen. Both the copy for testing institution of the custody and control form and test specimen sent to testing institution shall not include the name and ID No. of donor, or any other personal data sufficient for identification.
Article 6
Upon receipt of a urine specimen, the testing institution shall first confirm whether the specimen conforms to the description in the custody and control form. If any abnormity is found, the testing institution shall immediately notify the consignor and record it in the custody and control form.
Article 7
The testing institution shall take the following safety measures for the disposal of specimens and in the storage place of test data:
1. Any unauthorized person may not dispose the urine specimen or participate in the disposal conducted by the testing institution;
2. Any person may not enter the storage place of urine or data without being accompanied by authorized personnel; and
3. When an authorized person needs to dispose the urine specimen,participate in the disposal conducted by the testing institution or enter the storage place of data, the name, date and time shall be recorded.
Article 8
Upon receipt of a urine specimen, the testing institution shall store the specimen in a refrigerator below 6°C before proceeding drug test.
Article 9
The testing institution shall dispose the residual specimens in accordance with the relevant provisions or the agreement reached with the test consignor.
Except for juridical cases, a negative urine specimen shall be destroyed fourteen days after the test report is delivered.
The positive urine specimen shall be stored in a freezer below -20°C.
Article 10
The testing institution shall store the urine specimen (B) in freezer below -20°C, and all access operations shall be recorded in the custody and control form.
Article 10-1
Medical or research institutions that obtain the remaining urine specimens for research according to Paragraph 2, Article 33-1 of the Statute, shall comply with the provisions in the Human Subjects Research Act, the Personal Data Protection Act, and other relevant laws and regulations.
The specimens in the preceding paragraph shall not be applied in performing DNA tests or other tests sufficient to detect individual identities.
Article 10-2
For the obtaining as in the first paragraph of the preceding Article, the medical or research institution shall submit an application to the test consignor.
The test consignor, if approving the application mentioned in the preceding paragraph, shall provide the remaining urine specimens in a de-identification method, and in case the specimen is stored in the testing institution, shall notify the testing institution of the approval in writing so the specimen is obtainable.
The medical or research institutions shall not transfer the specimens obtained according to the first paragraph.
Article 10-3
The testing institution, when providing the specimen to the recipient in accordance with the second paragraph of the preceding Article, shall record the following items:
1. The serial number of specimen.
2. The amount of the specimen provided.
3. Appearance and characterization of the specimen.
4. The date and time of specimen provided.
5. The name of the obtaining institution.
6. The name of the person releasing the specimen and the person obtaining the specimen.
7. The approval document number of the test consignor.
The record in the preceding paragraph shall bear the signatures and/or the stamps of the person releasing the specimen and the person obtaining the specimen. The record shall be retained on file by the testing institution for at least two years.