Four, housing, facilities and layout of the basic requirements
(a) intravenous drug dispensing center (room) the overall regional design and layout, the setup of the functional room and the area should be compatible with the workload, and to ensure that the clean area, the auxiliary work area and the living area of the division of the different areas of the flow of people and logistics access to reasonable direction. Toward a reasonable, different clean level areas should have the appropriate facilities to prevent cross-contamination.
(2) intravenous drug preparation center (room) should be set up in a quiet area with little movement of people, and easy to communicate with medical staff and delivery of finished products. Set up the location should be far away from a variety of sources of pollution, is prohibited to set up in the basement or semi-basement, the surrounding environment, pavement, vegetation, etc. will not cause pollution to the quiet
vein medication dispensing process. Clean area air intake should be set in the surrounding 30 meters in the environment, clean, pollution-free areas, the height from the ground is not less than 3 meters.
(C) intravenous drug dispensing center (room) of the clean area, auxiliary work area should have the appropriate space to place the appropriate facilities and equipment; clean area should contain a dressing, secondary dressing and dispensing operation room; auxiliary work area should contain the appropriate storage of drugs and materials, review the printing of the prescription, the preparation of drugs, finished product verification, packaging and general dressing and other functional rooms.
(d) intravenous drug preparation center (room) room should have sufficient lighting, wall color should be suitable for human vision; ceiling, walls, floors should be flat, clean, non-slip, easy to clean, there shall be no shedding; clean area of the room ceiling, walls, floors shall not be cracked, can withstand cleaning and disinfection, the junction should be curved, the interface is tight; the building materials used should be Meet the environmental requirements.
(E) intravenous drug preparation center (room) clean area should be equipped with temperature, humidity, air pressure and other monitoring equipment and ventilation facilities, to maintain the temperature of the intravenous drug preparation room 18 ℃ ~ 26 ℃, relative humidity of 40% to 65%, to maintain a certain amount of fresh air intake.
(F) intravenous drug preparation center (room) clean area of the clean standard should be in line with relevant national regulations, by the statutory testing departments to test qualified before being put into use.
Requirements for the cleanliness level of each functional room:
1. primary locker room, laundry room for 100,000;
2. secondary locker room, drug mixing and blending operation room for 10,000;
3. laminar flow operation platform for 100.
Other functional rooms should be strengthened as a control area management, prohibit non-room personnel in and out. Clean area should be continuously fed into the fresh air, and maintain a positive pressure differential; antibiotics, hazardous drugs, intravenous drug dispensing clean area and the secondary locker room should be 5 to 10 Pa negative pressure differential between.
(VII) intravenous drug preparation center (room) should be based on the nature of the drug to establish different delivery, exhaust (return) air system. Exhaust should be in the downwind direction of the air outlet, the distance shall not be less than 3 meters or set up on different sides of the building.
(viii) drugs, materials storage and the surrounding environment and facilities should be able to ensure the quality of various types of drugs and safe storage, should be divided into refrigerated, cool and room temperature areas, the relative humidity of the warehouse 40% ~ 65%. The secondary drugstore should be clean and tidy, and the width of the door and passageway should be convenient for the handling of drugs and meet the fire safety requirements. There is to ensure that the drugs received, acceptance, storage, maintenance, unpacking and other operations appropriate housing space and equipment, facilities.
(ix) intravenous drug dispensing center (room) installed in the pool location should be appropriate, shall not cause contamination of intravenous drug dispensing, without floor drains; indoor should be set up to prevent dust and rodents, insects and other facilities to enter; shower and toilet should be set up separately outside the center (room), shall not be set up in the intravenous drug dispensing center (room).
Fifth, the basic requirements of instruments and equipment
(a) Intravenous drug preparation center (room) should have the appropriate instruments and equipment to ensure the operation of intravenous drug preparation, quality of finished products and supply service management. Instruments and equipment shall be certified by the national statutory departments.
(2) intravenous drug dispensing center (room) instruments and equipment selection and installation, should be consistent with easy to clean, disinfect and easy to operate, repair and maintenance. Measuring instruments are accurate and regularly calibrated. Repair and maintenance should be specialized records and archives.
(C) intravenous drug dispensing center (room) should be configured with a hundred biological safety cabinets for antibiotics and hazardous drugs for intravenous drug dispensing; set up nutritional drug dispensing room, equipped with a hundred horizontal laminar flow clean table for parenteral nutritional solutions and general infusion intravenous drug dispensing.
Six, drugs, supplies and materials basic requirements
(a) intravenous drug dispensing drugs, medical supplies and materials should be in accordance with the provisions of the unified procurement by the health care institutions and the relevant departments of pharmacy, should be in line with the relevant provisions.
(2) The storage of drugs, medical supplies and materials should have a suitable secondary library, according to its nature and storage conditions require classification and positioning of storage, and shall not be stacked in the aisle or clean area.
(C) the storage and maintenance of drugs should be strictly in accordance with the "centralized dispensing of intravenous drugs operating procedures" and other relevant provisions of the implementation. Intravenous drug dispensing injection should be used in accordance with the Chinese Pharmacopoeia intravenous injection quality requirements.
(d) intravenous drug dispensing syringes and other apparatus used, should be used in accordance with national standards of single-use products, should check the packaging before use, such as damage or more than the expiration date shall not be used.