1. Process in accordance with the Kaohsiung City Government Health Bureau's letter No. 11533522200 dated April 9, 115.
2. Laboratories and storage sites that use or store Biosafety Level 2 to Level 4 pathogens must, each quarter, conduct at least one inventory of the items and quantities (weights) used or stored, and update and confirm the data in the designated system; the CDC regularly audits, in January, April, July, and October each year, the data maintenance and confirmation reports for the preceding quarter in the designated system for the designated units and their laboratories/storage sites; and based on the audit results, implement strengthened supervisory measures:
(a) If a designated unit accumulates two quarters in a year without completing data maintenance and reporting, the health authority will list it as a priority unit for on-site laboratory biosafety inspection in the following year.
(b) If a designated unit accumulates three quarters in a year without completing data maintenance and reporting, the health authority, depending on the situation, will dispatch personnel to conduct an on-site laboratory biosafety inspection within the same year.
3. According to the data in the designated system as of March 31, 115, a total of 605 designated units nationwide have been approved as biosafety supervisors/biosafety committees; in the first quarter of 115, all relevant designated units and their laboratories/storage sites in this city have completed the required tasks within the stipulated deadline.
4. If the laboratories/storage sites established by a designated unit temporarily have no or no longer have a need to store, use, dispose of, or import/export biological pathogens, they may be handled according to the following principles:
(a) Temporarily depleted or no current need: For those with no storage need, the designated system can change the purpose of the involved items from “storage” to “use”; if there is no related need, the laboratory/storage site status can be set to “suspended.”
(b) Laboratory/storage site no longer has related needs: Persons with “designated unit manager” authority in the designated system should delete that laboratory/storage site from the system.
(c) When both the designated unit and its laboratories/storage sites no longer have related needs: Please follow the “Regulations for Approval and Modification of Designated Unit Biosafety Supervisors and Biosafety Committees” and apply through the designated system to cancel the approval of the biosafety management organization.
