The health administrative departments of the local people's governments at or above the county level shall supervise and manage the collection and supply of raw plasma and the production and operation of blood products in their administrative regions in accordance with the responsibilities set forth in Article 30 of these Regulations. Chapter II Management of Raw Material Plasma Article 4 The State implements a system of unified planning and setting up of single plasma stations.
The State Council administrative department of health, according to the approved national production of raw plasma demand, the layout of the single plasma station, the number and size of the overall planning. Provinces, autonomous regions and municipalities directly under the Central People's Government health administrative departments in accordance with the overall plan to develop the administrative region of the single plasma station setup planning and collection of plasma regional planning, and reported to the State Council administrative department of health for the record. Article 5 The single plasma collection station is set up by the blood product production unit or by the health administrative department of the people's government at the county level, specializing in single plasma collection activities, with independent legal personality. Any other units and individuals shall not engage in single plasma collection activities. Article 6 To set up a single plasma collection station, must have the following conditions:
(1) in line with the single plasma collection station layout, number, size of the planning;
(2) with the collection of raw plasma and the collection of health professionals and technicians;
(3) with the collection of raw plasma and the hygienic environment of the premises;
(4) with the identification of plasma donors identification system;
(4) with the identification of plasma donors; and
(5) with the identification of plasma donors. Plasma supplier identification system;
(e) with the collection of raw plasma and the collection of raw plasma machinery and other facilities;
(f) with the collection of raw plasma quality inspection of technical personnel and the necessary instruments and equipment. Article 7 The application for the establishment of single plasma station, by the people's governments at the county level of the health administrative department of the initial examination, by the district of the city, the autonomous regional people's governments of the health administrative department or the people's governments of the provinces, autonomous regions, autonomous regions, municipalities directly under the Central People's Government of the people's Government of the health administrative department for examination and approval; the examination of conditions, by the people's governments of the provinces, autonomous regions, municipalities directly under the Central People's Government of the people's Health Administrative departments of the provincial, autonomous regions, municipalities directly under the People's Government of the People's Republic of China issued "single plasma license", and reported to the State Council administrative department of health for the record.
Single-collection plasma stations can only screen and collect plasma from plasma suppliers within the areas designated by the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. Article VIII of the "single plasma collection license" shall specify the period of validity. Article IX in a plasma collection area, only one single plasma collection station.
It is strictly prohibited for a single plasma collection station to collect plasma from plasma suppliers and other persons not within the demarcated area. Article 10 single plasma collection stations must be plasma donors for health checks; qualified, by the health administrative department of the people's government at the county level to issue the "plasma supply certificate".
The plasma supplier health inspection standards, developed by the State Council administrative department of health. Article XI "plasma certificate" by the provincial, autonomous regions and municipalities directly under the Central People's Government health administrative department responsible for the design and printing. Plasma supply certificate shall not be altered, forged or transferred. Article 12 Before collecting plasma, the single plasma collection station must identify the plasma supplier and verify his/her "plasma supply certificate", and if it is confirmed that there is no mistake, then the plasma supplier can carry out the health check and blood test in accordance with the prescribed procedures; if the plasma supplier passes the check and test, the plasma supplier shall collect the plasma in accordance with the relevant technical operation standards and procedures, and establish the plasma supplier's record file of the health check and plasma supplier; if he/she fails in the check and test, the single plasma collection station shall collect the "plasma supply certificate" and the "plasma supplier certificate". Plasma station to collect the "plasma supply certificate", and by the local people's government at the county level health administrative departments to supervise the destruction.
It is strictly prohibited to collect plasma from those who do not have the Plasma Supply Certificate.
Technical operation standards and procedures for plasma collection by the State Council administrative department of health. Article XIII of the single plasma station can only sign a quality responsibility with its blood products production units to supply raw plasma, is strictly prohibited to any other units to supply raw plasma. Article 14 The single plasma station must use single plasma collection machinery to collect plasma, it is strictly prohibited to collect plasma by hand. Collected plasma must be frozen according to a single portion of preservation, not mixed plasma.
It is strictly prohibited to single plasma station collection of blood or the collection of raw plasma for clinical use. Article XV of the single plasma station must be used with product approval number and by the State Drug and Biological Products Certification Organization batch by batch of qualified in vitro diagnostic reagents, as well as qualified disposable plasma collection equipment.
The plasma equipment and other disposable consumables after use, must be destroyed in accordance with relevant state regulations, and make records. Article XVI of the collection of raw plasma mono plasma station packaging, storage, transportation, must comply with state health standards and requirements. Article XVII of the single plasma station must be in accordance with the Law on the Prevention and Control of Infectious Diseases and its implementing measures and other relevant provisions, the strict implementation of disinfection management and epidemic reporting system. Article XVIII of the single plasma station should be half a year to the location of the county-level people's government health administrative departments to report on the collection of raw plasma, while copying to the municipalities, autonomous regions of the people's governments of the people's health administrative departments or provinces, autonomous regions of the people's government set up to send organs of the health administrative agencies and provinces, autonomous regions, municipalities directly under the Central People's Government health administrative departments. Provinces, autonomous regions, municipalities directly under the Central People's Government health administrative department shall report to the State Council annually to the State Council administrative department of health summary of the collection of raw plasma in the administrative region.