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Medical laboratory design standards
Medical laboratory design standards
1. Plane layout
a. The clinical laboratory should be located in the outpatient building, and should form a separate area. The area of the laboratory department of a tertiary hospital should not be less than 1200㎡, and the area of the laboratory department of a second-class hospital should not be less than 800㎡. If the laboratory department also undertakes more The scientific research and teaching tasks, the area should also be appropriately increased.
b. The plane layout of the laboratory department should be able to clearly distinguish the clean area, semi-contaminated area and polluted area. There should be partitions between each area. The clean area is mainly composed of changing rooms, offices, etc., and the semi-contaminated area is mainly composed of reagent warehouses. The contaminated area is mainly composed of a blood collection room and a testing laboratory.
c. The laboratory department should separate the flow of personnel, and there should be independent entrances and exits for personnel and goods. In particular, there should be special exits for waste, and they should be sent to the centralized medical waste storage point of the hospital through the hospital's sewage elevator, and the hospital's passenger elevator should not be used.
d. In order to ensure the safety of the testing work, the biosafety laboratory should meet the requirements of BSL-2 level laboratories, and non-manual hand washing devices and emergency eyewashing devices should be installed at the exit of the biosafety laboratory, and some high-pollution risk work It should be performed in a Class II biological safety cabinet.
(1) HIV primary screening laboratory: divided into clean area, semi-polluted area and polluted area, the area should not be less than 45㎡.
(2) PCR laboratory: divided into reagent preparation room, sample preparation room, and amplification analysis room. There must be a buffer room in front of each laboratory. The total PCR area should not be less than 60 square meters.
(3) Microbiology laboratory: divided into preparation room, buffer room and work area, the area should not be less than 35㎡.
(4) The blood collection area should be divided into a separate area. The length of the blood collection window should not be less than 1.2m, and the width should be 45-60cm. The number of blood collection windows should be determined with reference to the average number of outpatients per day, and due consideration should be given to future development needs.
(5) The design of the biochemical area should focus on the biochemical machine. The replacement speed of the biochemical machine is very fast. Before the design, it is necessary to contact the equipment manufacturer to determine the parameters such as the placement position, specification, weight, power, and water consumption of the equipment.
2. Clean decoration requirements
a. Wall panels and ceiling materials are required to be easy to clean and disinfect, scrub-resistant, dust-free, non-cracking, smooth and waterproof. Commonly used materials are double-sided sandwich color steel plates, and the fire rating is not lower than flame-retardant B1.
b. The ground material requires seamless non-slip and corrosion-resistant ground. Commonly used decorative materials are PVC or rubber ground. The joints of the paving must be welded and planed with the same color welding rod.
c. Requirements for the door of the laboratory: it should be able to close automatically. The door should be equipped with an observation window, with a door lock and a door closer. A working status indicator light can be installed on the door to indicate whether there is anyone working in the laboratory.
d. Requirements for windows in the laboratory: It is not suitable to set openable outer windows on the wall, and airtight observation windows can be set up.
e. The junction of the wall and the wall, the junction of the wall and the ground, and the junction of the wall and the ceiling of the laboratory should be treated with arcs, and the joints of the color steel plates should be treated with sealant to ensure the air quality of the laboratory. Tightness.
f. The ceiling height of the laboratory should be 2.6m high, and the ceiling of the main laboratory cannot be opened with manholes or equipment inspection holes.
g. New materials that have appeared in clean laboratory decoration in recent years:
(1) Double-layer tempered glass windows with adjustable shutters: double-layer tempered glass with a thickness of 8 mm and built-in adjustable shutters can increase the lighting and visual effects of the hall. The built-in shutters are pollution-free and do not need to be cleaned.
(2) Quickly assembled metal wall panels: mainly used as lightweight partition walls, with painted metal panels on both sides, filled with inorganic magnesium, compared with color steel panels, it has the advantages of high fire resistance, rich colors, and good wall texture. .
(3) Antibacterial wallboard: It is mainly used for interior wall decoration. The surface of gypsum board and metal plate is coated with high-performance fluorocarbon coating and ceramic inorganic coating. The surface is dense and dust-free, resistant to scrubbing, acid and alkali corrosion, and It has a certain antibacterial effect and can be used for wall decoration in clean rooms.
3. Ventilation and air conditioning engineering
a. The purification laboratory should avoid the situation that multiple laboratories share one air-conditioning unit. A separate air-conditioning unit can effectively avoid cross-contamination and save operating costs.
b. The design parameters of laboratory air conditioners should refer to the relevant requirements of the "Technical Specifications for Construction of Biosafety Laboratories", and the heat and humidity loads of biological safety cabinets, centrifuges, incubators and other equipment should also be considered during design.
c. The air purification system should be equipped with coarse, medium and high three-stage air filtration. The coarse-effect filter should be installed at the fresh air outlet, the medium-effect filter should be in the positive pressure section of the air conditioning unit, and the high-efficiency filter should be installed in the air supply of the system. end.
d. The height of the fresh air outlet from the ground should not be lower than 2.5m. The fresh air outlet should be protected from rain and rodents, and should be equipped with a filter screen that is easy to remove and clean.
e. The exhaust fan in the laboratory should be interlocked with the supply fan. The exhaust fan should be turned on before the supply fan and closed after the supply fan. The indoor exhaust duct should be set separately from the exhaust duct of biological safety cabinets and other equipment.
f. The air supply and exhaust in the clean room should be sent up and down. The indoor air supply and exhaust outlets should be arranged to minimize the space where the indoor airflow stagnates.
g. A pressure difference of not less than 5Pa should be maintained between the various areas of the laboratory to ensure that the airflow flows from the clean area to the polluted area, and a pressure differential gauge should be set at a position that is easy to observe.
h. Filters and air-conditioning units cannot use wooden materials, and should be resistant to disinfectant corrosion and non-absorbent materials, and the air leakage rate of air-conditioning units should be less than 2%.
i. Comfortable air-conditioning mainly adopts fan coil unit plus fresh air system, and uses the centralized cold and heat sources of the hospital in winter and summer. If the hospital has no cold and heat sources in spring and autumn, it can provide its own air-cooled modular unit to provide cold and heat sources.
4. Electrical Engineering
The laboratory of the laboratory should be powered according to the first-level load, and an uninterruptible power supply should be installed to ensure that the power supply of the main equipment is not less than 30 minutes.
a. Lighting system
(1) Laboratory illumination ≥ 300 lx, buffer room, preparation room ≥ 200 lx, office area illumination ≥ 200 lx, blood collection table top illumination ≥ 500 lx.
(2) Airtight lamps should be used in the purification area, and ordinary lamps can be used in the ordinary experimental area according to the ceiling material.
(3) The laboratory should be equipped with an ultraviolet sterilizing lamp, and can be equipped with an ultraviolet lamp (30W) according to 10-15㎡.
(4) The quantity and location of evacuation indicator lights, emergency lights, and exit indicator lights shall be designed in accordance with relevant fire protection regulations.
b. Power distribution system
(1) Enough sockets should be set up during electrical design, and the power consumption of the main equipment in the laboratory should be known in advance, and a special distribution box should be set up in the biosafety laboratory.
(2) Before designing the uninterruptible power supply, communicate with the person in charge of the laboratory to determine the equipment that needs uninterruptible power supply and the shortest power supply time. The location where the uninterruptible power supply is placed should be well ventilated.
c. Weak current system
(1) Telephone network terminals: There should be enough telephone network terminals in the laboratory to meet the requirements of laboratory information management.
(2) Access control system: It can restrict the entry of unauthorized personnel to ensure the safety of the laboratory.
(3) Monitoring system: It can monitor the entry and exit of laboratory personnel, daily work conditions, video teaching, etc.
(4) Call system: An emergency call extension should be set up in the laboratory, and the call host should be set up in the duty room.
5. Water supply, drainage and gas supply projects
a. Water supply system There should be a hand washing device at the exit of the laboratory. The hand washing device should use a non-manual faucet. The biosafety laboratory recommends that the inspection zone net be equipped with an automatic hand disinfection device. The water supply material meets the relevant national requirements.
b. Drainage system Floor drains should not be installed in the clean laboratory. The laboratory drainage should be separated from the living area drainage. It should be ensured that the laboratory drainage enters the hospital sewage treatment station.
c. Pure water system The equipment that mainly uses pure water in the laboratory is a biochemical analyzer. The laboratory pure water system should communicate with the person in charge of the laboratory before designing the pure water water point and the water consumption of each water point.
6. Laboratory supporting furniture
a. Laboratory furniture can be divided into three categories:all phenolic furniture, all-steel furniture, steel-wood furniture, and all-wood furniture according to the materials used. All phenolic furniture and All-steel furniture has a beautiful appearance but the price is high. The disadvantages of load-bearing and waterproof have been rarely used, and appropriate furniture should be selected in consideration of the hospital's budget.
b. The material of the experimental table is mainly made of solid phenolic board, epoxy resin board and Trespa. Since there are not many high-temperature equipment used in laboratory laboratories, it is recommended to use solid phenolic resin worktop and Trespa worktop
c. The length and style of the test bench should be determined according to the actual situation on site and the work needs before production. Too much furniture will occupy the working space, and insufficient furniture will affect the work.
7. New technologies applied in laboratory construction
a. The pneumatic pipeline transmission system closely connects various departments of the hospital with special transmission pipelines to form a closed pipeline network. The test zone network travels between arbitrary stations, and the system can deliver automatic transfers of samples, medicines, and other portable items. The system can improve the work efficiency of the hospital, save the working time and labor intensity of the medical staff, make the hospital logistics more orderly, and effectively avoid the cross-infection caused by the flow of people and contact, and reduce the flow of small items in the hospital from the traditional The manual transmission has become an automated intelligent transmission.
b. The experimental multi-function column is to lead the strong electricity, weak electricity, air source and water source from the ceiling to the working surface through the multi-function column. There are standard ports on the multi-function column for access during the experiment. The column is divided into multiple Strong electricity, weak electricity, water, and gas are in an independent area to avoid contact with each other.
8, the construction party's preparations
a. Understand the existing testing items of the laboratory and the testing items planned to be carried out in the past 3 years, understand the daily outpatient volume and the number of beds in the hospital, so as to determine the functional room and area of the testing laboratory.
b. Make a list of the main testing equipment in the laboratory. The list should include information such as equipment name, quantity, power, water consumption, and gas consumption, and provide it for the designer's reference.
c. The designer should provide a floor plan of the building, and negotiate with the engineering designer to determine the entrance and exit of the laboratory personnel, the entrance of cleaning items, and the exit of dirt. These human flow routes should not conflict with the human flow routes of the entire building.
d. After the preliminary design scheme is determined, the designer should be assisted in a communication with experts in the industry to optimize the design scheme.
a. The clinical laboratory should be located in the outpatient building, and should form a separate area. The area of the laboratory department of a tertiary hospital should not be less than 1200㎡, and the area of the laboratory department of a second-class hospital should not be less than 800㎡. If the laboratory department also undertakes more The scientific research and teaching tasks, the area should also be appropriately increased.
b. The plane layout of the laboratory department should be able to clearly distinguish the clean area, semi-contaminated area and polluted area. There should be partitions between each area. The clean area is mainly composed of changing rooms, offices, etc., and the semi-contaminated area is mainly composed of reagent warehouses. The contaminated area is mainly composed of a blood collection room and a testing laboratory.
c. The laboratory department should separate the flow of personnel, and there should be independent entrances and exits for personnel and goods. In particular, there should be special exits for waste, and they should be sent to the centralized medical waste storage point of the hospital through the hospital's sewage elevator, and the hospital's passenger elevator should not be used.
d. In order to ensure the safety of the testing work, the biosafety laboratory should meet the requirements of BSL-2 level laboratories, and non-manual hand washing devices and emergency eyewashing devices should be installed at the exit of the biosafety laboratory, and some high-pollution risk work It should be performed in a Class II biological safety cabinet.
(1) HIV primary screening laboratory: divided into clean area, semi-polluted area and polluted area, the area should not be less than 45㎡.
(2) PCR laboratory: divided into reagent preparation room, sample preparation room, and amplification analysis room. There must be a buffer room in front of each laboratory. The total PCR area should not be less than 60 square meters.
(3) Microbiology laboratory: divided into preparation room, buffer room and work area, the area should not be less than 35㎡.
(4) The blood collection area should be divided into a separate area. The length of the blood collection window should not be less than 1.2m, and the width should be 45-60cm. The number of blood collection windows should be determined with reference to the average number of outpatients per day, and due consideration should be given to future development needs.
(5) The design of the biochemical area should focus on the biochemical machine. The replacement speed of the biochemical machine is very fast. Before the design, it is necessary to contact the equipment manufacturer to determine the parameters such as the placement position, specification, weight, power, and water consumption of the equipment.
2. Clean decoration requirements
a. Wall panels and ceiling materials are required to be easy to clean and disinfect, scrub-resistant, dust-free, non-cracking, smooth and waterproof. Commonly used materials are double-sided sandwich color steel plates, and the fire rating is not lower than flame-retardant B1.
b. The ground material requires seamless non-slip and corrosion-resistant ground. Commonly used decorative materials are PVC or rubber ground. The joints of the paving must be welded and planed with the same color welding rod.
c. Requirements for the door of the laboratory: it should be able to close automatically. The door should be equipped with an observation window, with a door lock and a door closer. A working status indicator light can be installed on the door to indicate whether there is anyone working in the laboratory.
d. Requirements for windows in the laboratory: It is not suitable to set openable outer windows on the wall, and airtight observation windows can be set up.
e. The junction of the wall and the wall, the junction of the wall and the ground, and the junction of the wall and the ceiling of the laboratory should be treated with arcs, and the joints of the color steel plates should be treated with sealant to ensure the air quality of the laboratory. Tightness.
f. The ceiling height of the laboratory should be 2.6m high, and the ceiling of the main laboratory cannot be opened with manholes or equipment inspection holes.
g. New materials that have appeared in clean laboratory decoration in recent years:
(1) Double-layer tempered glass windows with adjustable shutters: double-layer tempered glass with a thickness of 8 mm and built-in adjustable shutters can increase the lighting and visual effects of the hall. The built-in shutters are pollution-free and do not need to be cleaned.
(2) Quickly assembled metal wall panels: mainly used as lightweight partition walls, with painted metal panels on both sides, filled with inorganic magnesium, compared with color steel panels, it has the advantages of high fire resistance, rich colors, and good wall texture. .
(3) Antibacterial wallboard: It is mainly used for interior wall decoration. The surface of gypsum board and metal plate is coated with high-performance fluorocarbon coating and ceramic inorganic coating. The surface is dense and dust-free, resistant to scrubbing, acid and alkali corrosion, and It has a certain antibacterial effect and can be used for wall decoration in clean rooms.
3. Ventilation and air conditioning engineering
a. The purification laboratory should avoid the situation that multiple laboratories share one air-conditioning unit. A separate air-conditioning unit can effectively avoid cross-contamination and save operating costs.
b. The design parameters of laboratory air conditioners should refer to the relevant requirements of the "Technical Specifications for Construction of Biosafety Laboratories", and the heat and humidity loads of biological safety cabinets, centrifuges, incubators and other equipment should also be considered during design.
c. The air purification system should be equipped with coarse, medium and high three-stage air filtration. The coarse-effect filter should be installed at the fresh air outlet, the medium-effect filter should be in the positive pressure section of the air conditioning unit, and the high-efficiency filter should be installed in the air supply of the system. end.
d. The height of the fresh air outlet from the ground should not be lower than 2.5m. The fresh air outlet should be protected from rain and rodents, and should be equipped with a filter screen that is easy to remove and clean.
e. The exhaust fan in the laboratory should be interlocked with the supply fan. The exhaust fan should be turned on before the supply fan and closed after the supply fan. The indoor exhaust duct should be set separately from the exhaust duct of biological safety cabinets and other equipment.
f. The air supply and exhaust in the clean room should be sent up and down. The indoor air supply and exhaust outlets should be arranged to minimize the space where the indoor airflow stagnates.
g. A pressure difference of not less than 5Pa should be maintained between the various areas of the laboratory to ensure that the airflow flows from the clean area to the polluted area, and a pressure differential gauge should be set at a position that is easy to observe.
h. Filters and air-conditioning units cannot use wooden materials, and should be resistant to disinfectant corrosion and non-absorbent materials, and the air leakage rate of air-conditioning units should be less than 2%.
i. Comfortable air-conditioning mainly adopts fan coil unit plus fresh air system, and uses the centralized cold and heat sources of the hospital in winter and summer. If the hospital has no cold and heat sources in spring and autumn, it can provide its own air-cooled modular unit to provide cold and heat sources.
4. Electrical Engineering
The laboratory of the laboratory should be powered according to the first-level load, and an uninterruptible power supply should be installed to ensure that the power supply of the main equipment is not less than 30 minutes.
a. Lighting system
(1) Laboratory illumination ≥ 300 lx, buffer room, preparation room ≥ 200 lx, office area illumination ≥ 200 lx, blood collection table top illumination ≥ 500 lx.
(2) Airtight lamps should be used in the purification area, and ordinary lamps can be used in the ordinary experimental area according to the ceiling material.
(3) The laboratory should be equipped with an ultraviolet sterilizing lamp, and can be equipped with an ultraviolet lamp (30W) according to 10-15㎡.
(4) The quantity and location of evacuation indicator lights, emergency lights, and exit indicator lights shall be designed in accordance with relevant fire protection regulations.
b. Power distribution system
(1) Enough sockets should be set up during electrical design, and the power consumption of the main equipment in the laboratory should be known in advance, and a special distribution box should be set up in the biosafety laboratory.
(2) Before designing the uninterruptible power supply, communicate with the person in charge of the laboratory to determine the equipment that needs uninterruptible power supply and the shortest power supply time. The location where the uninterruptible power supply is placed should be well ventilated.
c. Weak current system
(1) Telephone network terminals: There should be enough telephone network terminals in the laboratory to meet the requirements of laboratory information management.
(2) Access control system: It can restrict the entry of unauthorized personnel to ensure the safety of the laboratory.
(3) Monitoring system: It can monitor the entry and exit of laboratory personnel, daily work conditions, video teaching, etc.
(4) Call system: An emergency call extension should be set up in the laboratory, and the call host should be set up in the duty room.
5. Water supply, drainage and gas supply projects
a. Water supply system There should be a hand washing device at the exit of the laboratory. The hand washing device should use a non-manual faucet. The biosafety laboratory recommends that the inspection zone net be equipped with an automatic hand disinfection device. The water supply material meets the relevant national requirements.
b. Drainage system Floor drains should not be installed in the clean laboratory. The laboratory drainage should be separated from the living area drainage. It should be ensured that the laboratory drainage enters the hospital sewage treatment station.
c. Pure water system The equipment that mainly uses pure water in the laboratory is a biochemical analyzer. The laboratory pure water system should communicate with the person in charge of the laboratory before designing the pure water water point and the water consumption of each water point.
6. Laboratory supporting furniture
a. Laboratory furniture can be divided into three categories:all phenolic furniture, all-steel furniture, steel-wood furniture, and all-wood furniture according to the materials used. All phenolic furniture and All-steel furniture has a beautiful appearance but the price is high. The disadvantages of load-bearing and waterproof have been rarely used, and appropriate furniture should be selected in consideration of the hospital's budget.
b. The material of the experimental table is mainly made of solid phenolic board, epoxy resin board and Trespa. Since there are not many high-temperature equipment used in laboratory laboratories, it is recommended to use solid phenolic resin worktop and Trespa worktop
c. The length and style of the test bench should be determined according to the actual situation on site and the work needs before production. Too much furniture will occupy the working space, and insufficient furniture will affect the work.
7. New technologies applied in laboratory construction
a. The pneumatic pipeline transmission system closely connects various departments of the hospital with special transmission pipelines to form a closed pipeline network. The test zone network travels between arbitrary stations, and the system can deliver automatic transfers of samples, medicines, and other portable items. The system can improve the work efficiency of the hospital, save the working time and labor intensity of the medical staff, make the hospital logistics more orderly, and effectively avoid the cross-infection caused by the flow of people and contact, and reduce the flow of small items in the hospital from the traditional The manual transmission has become an automated intelligent transmission.
b. The experimental multi-function column is to lead the strong electricity, weak electricity, air source and water source from the ceiling to the working surface through the multi-function column. There are standard ports on the multi-function column for access during the experiment. The column is divided into multiple Strong electricity, weak electricity, water, and gas are in an independent area to avoid contact with each other.
8, the construction party's preparations
a. Understand the existing testing items of the laboratory and the testing items planned to be carried out in the past 3 years, understand the daily outpatient volume and the number of beds in the hospital, so as to determine the functional room and area of the testing laboratory.
b. Make a list of the main testing equipment in the laboratory. The list should include information such as equipment name, quantity, power, water consumption, and gas consumption, and provide it for the designer's reference.
c. The designer should provide a floor plan of the building, and negotiate with the engineering designer to determine the entrance and exit of the laboratory personnel, the entrance of cleaning items, and the exit of dirt. These human flow routes should not conflict with the human flow routes of the entire building.
d. After the preliminary design scheme is determined, the designer should be assisted in a communication with experts in the industry to optimize the design scheme.
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