Each batch of initial test specimens shall include the following quality control urines:
1. At least one urine specimen without the drugs to be tested or their metabolites.
2. At least one specimen of quality control urine with a concentration of the drugs to be tested or their metabolite about 25% above the cutoff value.
3. At least one specimen of quality control urine with a concentration of the drugs to be tested or their metabolites about 25% below the cutoff value.
4. At least one specimen of blind quality control urine prepared by the testing institution itself.
If a single method of the initial test can be applied on ten or more drugs or their metabolites, the testing institution shall select at least ten drugs or their metabolites as quality control items. The selected items shall be reviewed annually.
For the selection of the quality control items as in the preceding paragraph, priority shall be given to those drugs or their metabolites frequently detected.

Each batch of initial test specimens shall include at least 10% of quality control urines, and at least among 1% of the blind quality control urines prepared by the testing institution itself.

Each batch of confirmatory test specimens shall include the following quality control urines:
1. Single-point calibration specimen at the cutoff value.
2. At least a urine specimen without the drugs to be tested or their metabolites.
3. At least one specimen of positive quality control urine with a concentration of the drugs to be tested or their metabolites about 25% above the cutoff value .
4. At least one specimen of negative quality control urine with a concentration of the drugs to be tested or their metabolites about 25% below the cutoff value .
5. At least one specimen of blind quality control urine prepared inside the testing institution.

Each batch of confirmatory test specimens shall include at least 10% of quality control urines

Each batch of retest specimens shall include at least one specimen of quality control urines with a concentration of the drugs or their metabolites 40% below the cutoff value.

The linearity, precision and accuracy of the confirmatory test methods of the testing institutions shall be validated at least once every year.

The testing institutions shall prescribe a quality assurance plan of the testing procedures, including the procedures of specimen management, initial and confirmatory test methods, and test reports, and designate full-time personnel to carry through the plan.

The testing institutions shall work out procurement procedure and acceptance standards conforming to the quality requirements for the material and technical services regarding urine test, and keep the related recording documents.

The testing institutions shall prescribe the principles for settling the disputes raised by the test consignor.

The testing institutions shall prescribe the procedures for internal periodical audit and management review.