Spatial planning is the most important part of the design of an intelligent medical laboratory. Adequate laboratory space is the foundation for ensuring the quality of laboratory testing and the safety of staff. Insufficient space is a safety hazard in the laboratory and affects the quality of laboratory work.

Section 1 Spatial Design of Intelligent Medical Laboratories

Spatial planning must not only meet biosafety requirements and accommodate workflow, and determine the rational allocation of space according to the needs of the equipment to be placed, but should also determine the size of the laboratory space with a developmental perspective, so that newly acquired instruments and equipment can be accommodated over a relatively long period, ensuring efficient and safe completion of the testing work of the medical laboratory.

I. Principles of Spatial Design for Medical Laboratories

The spatial design of an intelligent medical laboratory must strictly follow the following principles:

scientific functional zoning; rational layout and workflow; clearly separated clean and contaminated routes; space reserved for development; rational use of floor area; and ensuring work safety.

1. Scientific Functional Zoning

In its overall design, an intelligent medical laboratory must clearly delineate the clean area, the semi-contaminated area (buffer area), and the contaminated area, and there must be clear physical partitions or enclosing structures between the zones. At the main entrance of the laboratory there must be a "biohazard warning sign" and an access control system that restricts entry by outsiders.

1.1 The clean area refers to the relatively clean area, including areas for office work, study, and staff rest.

1.2 The semi-contaminated area (buffer area) refers to an area with a relatively low risk of contamination, or a transitional area located between the clean area and the contaminated area.

1.3 The contaminated area is also called the laboratory containment area. Within this area the biological risk is relatively high, and it is an area requiring control over the laboratory's floor plan, the airtightness of its enclosing structures, airflow, as well as personnel entry and personal protective equipment. 1.4 In the specific design of special laboratories in an intelligent medical laboratory, such as HIV screening and microbiology laboratories, PCR laboratories, mycology laboratories, and tuberculosis laboratories, relevant national standards and requirements must be strictly implemented in functional zoning, pressure gradients, and airflow direction design.

2. Rational Layout and Workflow

In its overall design, an intelligent medical laboratory must attach importance to and optimize its layout and workflow. A rational layout and workflow must fully embody the following principles:

2.1 Shortest-path principle In designing the laboratory, the shortest path must be considered, that is, allowing staff to take the shortest route and do the most work; only in this way can maximum efficiency be achieved. At the same time, the path design of the laboratory should also fully consider the convenience of patients, embodying to the greatest extent a "one-stop" medical laboratory service for patients.

2.2 Contamination-gradient principle In designing the laboratory, the risk level of each experimental unit should be considered; the experimental units with lighter contamination should be located closer to the clean area, and the experimental units with heavier contamination should be located farther from the clean area.

3. Clearly Separated Clean and Contaminated Routes

In designing the laboratory, the waste transport route must first be considered and determined. Then, based on the established waste transport route, the routes for each experimental unit and for personnel and material flow should be designed. The following must be achieved:

3.1 Separate routing of personnel flow and material flow 3.2 Separate routing of patients and staff 3.3 Separate routing of clean items and contaminated items 3.4 The waste transport route should, to the greatest extent possible, avoid public passageways and the clean area of the laboratory 3.5 The waste transport route should be close to the waste elevator

4. Reserving Space for Development

In its overall design, an intelligent medical laboratory must attach importance to reserving space for development.

4.1 The pace of development of medical laboratory science and the introduction of new test items must be fully considered 4.2 The acquisition of new large-scale equipment and the renewal of existing equipment must be fully considered 4.3 Electromagnetic interference between adjacent instruments and equipment must be fully considered 4.4 The laboratory should reserve an equipment passageway for moving large-scale equipment in and out

5. Rational Use of Floor Area

In both the overall design of an intelligent medical laboratory and the specific design of each functional unit, the following should be achieved:

5.1 The usable floor area of each functional unit must meet relevant national requirements 5.2 An overcrowded laboratory is a major biosafety hazard 5.3 Make rational use of effective area and minimize ineffective area 5.4 Overcrowding of equipment should be avoided as much as possible, while excessive redundancy is also effectively avoided

6. Ensuring Work Safety

In both the overall design of an intelligent medical laboratory and the specific design of each functional unit, safety must be put first. Laboratory safety includes:

6.1 Biosafety

6.1.1 In the supply and exhaust air design, the laboratory should achieve the following: the required pressure gradient and airflow direction of the laboratory should be maintained at all times.

6.1.2 The laboratory should be designed and fitted with emergency shower equipment, and eyewash devices should be installed in key experimental areas (the laboratory containment area).

6.1.3 The laboratory handwashing sinks should be fitted with non-hand-touch handwashing devices.
6.1.4 The laboratory should have space for the disinfection, sterilization, and storage of waste.
6.2 Medical Safety

6.2.1 The blood collection area of the laboratory should have a clear physical partition from the experimental area, to avoid collecting blood specimens in the contaminated area of the laboratory.

6.2.2 The blood collection area should have an emergency exit, so that treatment measures can be taken promptly when a patient faints from the needle.
6.3 Fire Safety

In both the overall design of an intelligent medical laboratory and the specific design of each functional unit, the design drawings should meet fire protection requirements or be reviewed and approved by the fire protection department.

6.3.1 The design of laboratory passageways must not include dead ends.

6.3.2 The laboratory must be designed with emergency passageways and exits; the emergency passageways and exits must be kept clear and must not be shared with other functional units.

6.3.3 Emergency passageways and exits must have clear signage and clearly indicate the direction of escape.
6.4 Environmental Safety

In both the overall design of an intelligent medical laboratory and the specific design of each functional unit, its functional design should meet environmental protection requirements or be reviewed and approved by the environmental protection department.

6.4.1 Contaminated gases from the laboratory must be filtered through high-efficiency particulate air (HEPA) filters before being discharged into the natural environment.

6.4.2 Contaminated waste from the laboratory must be sterilized in an autoclave (high-pressure steam sterilizer) or soaked in chemical disinfectant before it can leave the laboratory.

6.4.3 Wastewater from the laboratory must be disinfected and tested as qualified by the environmental protection department before it can be discharged into the drainage network.

6.4.4 All work and all items in the laboratory must not pose any potential hazard to the environment.

II. Spatial Design Requirements for Medical Laboratories

According to the Catalogue of Medical Institution Diagnosis and Treatment Subjects, medical laboratories include not only laboratory testing but also pathology diagnosis laboratories. Clinical laboratories include the following specialties: clinical body fluids and blood; clinical microbiology; clinical biochemistry testing; clinical immunology and serology; clinical cellular and molecular genetics; molecular diagnostics; and other specialties. Each specialty should have adequate working space. The department of pathology should be provided with a specimen receiving room, a specimen examination and grossing room, a routine pathology technology room, an immunohistochemistry room, a cytology slide preparation room, a pathology diagnosis room, a pathology archive room and specimen storage room, a frozen section room, a histochemical staining room, a molecular pathology room, a consultation room, a computer management room, a reference materials room, an academic activity room, a storeroom, etc., and each work unit should also have adequate working space.

Fig. 4-1 Three Zones of an Intelligent Medical Laboratory Fig. 4-2 Three Flows of an Intelligent Medical Laboratory

According to the Hospital Grading Management Standards, hospitals are assessed and classified into three grades, namely Grade I, Grade II, and Grade III. The independent floor space of the clinical laboratory of a Grade I hospital should reach over 100 m2. A Grade I hospital laboratory mainly includes a changing room, a clinical routine testing and biochemistry room, and an HIV screening laboratory (optional). The laboratory is relatively independent, separated from public areas by an isolation door, with the clean area, semi-contaminated area, and contaminated area clearly delineated. This is shown in Fig. 4-3 and Fig. 4-4. Fig. 4-3 Floor Plan Layout of an Intelligent Clinical Laboratory in a Grade I Hospital

Fig. 4-4 Floor Plan Layout of an Intelligent Clinical Laboratory in a Grade I Hospital

The independent floor space of the laboratory of a Grade II Class A hospital should reach over 1500 m2, and that of a Grade II Class B hospital should reach over 1000 m2. The laboratory floor plan must be planned according to the principle of three zones and three flows, and the three zones and three flows must not cross. The three zones are divided into the clean area, the semi-contaminated area, and the contaminated area. The clean area includes the office, meeting room, reference materials room, and duty room; the semi-contaminated area mainly refers to the changing room; the contaminated area mainly refers to the laboratory area. The laboratory area of a Grade II hospital includes the emergency testing room, clinical routine testing room, biochemistry room, immunology room, HIV screening laboratory, microbiology laboratory, PCR laboratory (optional), washing and disinfection room, cold storage, and storeroom. The three flows are divided into patient flow, medical staff flow, and waste flow. This is shown in Fig. 4-5 and Fig. 4-6. Fig. 4-5 Three Zones of an Intelligent Clinical Laboratory in a Grade II Hospital Fig. 4-6 Three Flows of an Intelligent Clinical Laboratory in a Grade II Hospital

The independent floor space of the clinical laboratory of a Grade III Class A hospital should reach over 2000-3000 m2, and that of a Grade III Class B hospital should reach over 1500-2000 m2. The laboratory floor plan must be planned according to the principle of three zones and three flows, and the three zones and three flows must not overlap. The three zones are divided into the clean area, the semi-contaminated area, and the contaminated area. The clean area includes the office, meeting room, reference materials room, and duty room; the semi-contaminated area mainly refers to the changing room; the contaminated area mainly refers to the laboratory area. The laboratory departments of a Grade III hospital include the emergency testing room, clinical routine testing room, biochemistry room, immunology room, sputum testing laboratory, flow cytometry room, trace elements room, HIV screening laboratory, microbiology laboratory, PCR laboratory, washing and disinfection room, cold storage, and storeroom. The three flows are divided into patient flow, medical staff flow, and waste flow. This is shown in Fig. 4-7 and Fig. 4-8.

Fig. 4-7 Three Zones of an Intelligent Clinical Laboratory in a Grade III Hospital

Fig. 4-8 Three Flows of an Intelligent Clinical Laboratory in a Grade III Hospital

The basic rooms of the department of pathology should include a grossing room, a slide preparation room, a diagnosis room, an archive room, and a specimen storage room. The department of pathology of a Grade II general hospital should be provided with a specimen receiving room, a specimen examination and grossing room, a routine pathology technology room, an immunohistochemistry room, a cytology slide preparation room, a pathology diagnosis room, a pathology archive room and specimen storage room; in addition to the requirements for Grade II hospitals, the department of pathology of a Grade III hospital should also be provided with a frozen section room, a histochemical staining room, a molecular pathology room, a teleconsultation room, a computer management room, a reference materials room, an academic activity room, a storeroom, etc.; a teaching base should have an independent study room for visiting physicians. The total floor area of the department of pathology in a Grade III hospital should generally be 600–1000 m2, and the floor area of a department of pathology in a Grade III Class A teaching hospital that also carries out molecular pathology testing should generally be greater than 2000 m2; the laboratory floor plan must be planned according to the principle of three zones and three flows, and the three zones and three flows must not overlap. The three zones are divided into the clean area, the semi-contaminated area, and the contaminated area. The clean area includes the office, meeting room, reference materials room, and study room; the semi-contaminated area mainly refers to the changing room; the contaminated area includes the slide reading room, specimen receiving room, specimen display room, pathology archive room, grossing room, pathology slide preparation room, pathology cytology room, immunofluorescence room, immunohistochemistry room, molecular pathology testing room, frozen section room, tissue dehydrator room, and storeroom. The department of pathology has an independent shower room and shower equipment. An autopsy room may be set up as needed. The autopsy room should be independently located, well ventilated, fully equipped with sewage treatment, disinfection, and shower facilities, and provided with corresponding special autopsy instruments. The three flows are divided into patient flow, medical staff flow, and waste flow.

The laboratory needs to be fitted with dedicated fume hoods (local ventilation), used respectively in the areas for grossing, preparing, and using harmful chemical reagents, so that the harmful exhaust gases generated during work are discharged through the fume hoods rather than diffusing throughout the laboratory. At the same time, the laboratory should also be fitted with good ventilation facilities such as exhaust fans (whole-room ventilation) to expel harmful exhaust gases from the laboratory.

Laboratories with contaminating operations should have ultraviolet lamps fixedly installed on the ceiling or walls (no more than 2.1 meters from the ground), or use movable ultraviolet lamps or other disinfection facilities for disinfection.

Fig. 4-9 Three Zones of the Department of Pathology

Fig. 4-10 Three Flows of the Department of Pathology

III. Floor Layout and Zoning of Medical Laboratories

The floor layout of the laboratory must be divided according to the principle of three flows and three zones. The three zones refer to the clean area, the semi-contaminated area, and the contaminated area. The clean area refers to the area mainly used for office work, study, and rest of laboratory personnel; the semi-contaminated area refers to the changing room, corridors, etc.; staff must pass through the changing room and change clothes before entering the laboratory area (contaminated area), and an access control system must be installed at the changing room so that non-staff cannot enter the laboratory. The contaminated area refers to all workspaces used for experimental operations and is the core area of the laboratory. The three flows refer to patient flow, medical staff flow, and waste flow; personnel flow and waste flow must be provided with independent passageways, achieving complete separation of personnel flow and material flow, and the waste passageway must connect to the waste elevator.

Fig. 4-11 Laboratory Clean Area

Fig. 4-12 Laboratory Semi-Contaminated Area

Fig. 4-13 Laboratory Contaminated Area

IV. Plan Dimensions of Medical Laboratory Functional Units

The functional unit is the basis of laboratory design. The width of a laboratory functional unit is generally set at 3.5~4.0 m, and the depth is based on the dimensions and structure required by the laboratory. If the functional unit is too wide, the ratio of its usable floor area will not achieve its due efficiency; if the functional unit is too narrow, the result is an aisle that is too narrow, causing inconvenience in work and creating an unsafe laboratory environment.

V. Spatial Planning of Medical Laboratories

1. Quantity

1.1 Rationalized Space

The rational allocation of space is determined according to the needs of the equipment to be placed. At the same time, the size of the laboratory space should be determined with a developmental perspective, so that newly acquired instruments and equipment can be accommodated over a relatively long period, ensuring efficient and safe completion of clinical work and durable use of the laboratory.

1.2 Space Allocation Principles

The overall principle of space allocation is to make staff feel comfortable without creating waste; factors such as the number of staff, analytical methods, and the size of instruments should be comprehensively considered in the integrated design and allocation.

2. Quality

2.1 Workspace

The size of the workspace should ensure that the maximum number of staff in the area can work at the same time. The effective space should be divided into the clean area (office, rest room, study room), the buffer area (changing room), and the contaminated area (experimental operation area). The work area should include the floor area occupied by staff and the space for moving back and forth. The workspace and movement space should be converted into the floor area occupied on the ground.

2.2 Storage Area and Supply Area

The size and location of the storage area and supply area have an important impact on the normal operation and safety of the laboratory. The storage area includes under-bench space, elevated shelving, refrigerated areas, and frozen areas.

3. Expansion

3.1 Expansion Plan

The laboratory design should consider expandability, that is, the ability to expand outward or mobility, to meet the needs of laboratory development.

4. Regulations and Safety

Laboratory design should strictly follow the requirements of relevant regulations. Architects have the responsibility to put forward requirements and design recommendations concerning relevant regulations.

5. Basic Principles

5.1 Space Assessment

Before formulating the space allocation plan, a comprehensive analysis should be made of factors such as instruments and equipment, the number of staff, workload, and experimental methods.

After carefully analyzing the various factors, the requirements for space standards should be assessed, and the net area and gross area of the zones should be calculated. For zones with special functions, the space allocated differs according to their different functions and activities.

5.2 Net Area and Gross Area

The net area of a laboratory refers to the actual workspace. Net area is the effectively functional part of laboratory design, while the additional area refers to the laboratory's machinery, electrical systems, pumps, and infrastructure. The net area of a zone is calculated as the total area divided by 1.35 (74%) to 1.55 (64%).

5.3 Arrangement (Layout) of the Laboratory

Designing a laboratory is an independent and concrete process. Three issues should be considered in the design, namely applicability, flexibility, and safety.

5.3.1 Specimen Transport and Personnel Movement

In allocating laboratory zones, applicability should first be considered, that is, the movement of staff and patients and the transport of specimens. The doors, workbenches, and instruments in each specific area of a laboratory should also be carefully laid out. Factors such as the number of instruments, equipment, and operation benches, personnel, supplies, and flow directions may all affect the actual space requirements. Mechanical adaptability also includes: the type and capacity of the air handling system, the use of pumps, and the maintenance and reconstruction of piping.

5.3.2 Flexibility

Highly flexible workbenches can be used in order to reduce expenditure and adapt to future development.

5.3.3 Safety

The design and size of the laboratory should consider safety, meet the building codes for emergency clearance and evacuation exits, and be equipped with safety equipment according to the conditions of each laboratory.

All laboratories and places in direct contact with patients should be fitted with handwashing sinks. The sinks should preferably be located at the exit to remind staff that they must wash their hands before leaving the laboratory. The handwashing sinks should be independently dedicated and must not be shared with specimen processing and experiments.

Within 30 meters of hazardous chemical reagents, an emergency eyewash station and an emergency shower should be provided.

Safety devices usable by all laboratories (handwashing sinks, emergency showers, emergency eyewash stations, fire protection equipment, etc.) should be placed in prominent, easily reachable positions, so that staff can easily find them in an emergency.

5.3.4 Consideration for Disabled Employees

Laboratory design should also take into account staff with disabilities; for example, the work area should also be suitable for disabled persons to enter, leave, and work. Ancillary equipment at workbenches should be convenient for both disabled and able-bodied persons to use.

VI. Relevant Space Standards for Medical Laboratory Areas

1. Indoor Clear Height

Indoor clear height of changing rooms and laboratories: when air conditioning is not installed, the space height should not be lower than 2.6 m; when air conditioning is installed, the space height should not be lower than 2.4 m. The indoor clear height of the laboratory should also be determined according to the dimensions of laboratory instruments and equipment and the requirements for installation and maintenance.

2. Bay Width

The bay width of a standard laboratory unit should be determined by the laboratory width, the arrangement method, and the spacing.

3. Windows

On the premise of meeting lighting requirements, the transparency and openness of the laboratory should also be ensured.

4. Doors

The width of the main entrance door of a general laboratory passageway is 1.5 m; the door width of a laboratory where large instruments and equipment need to be placed is generally 1.2 m; the door width of the other departments is generally 0.9 m. Laboratory doors should be provided with observation windows.

5. Spacing Between Workbenches

The width of the passageway between workbenches is generally 1.5~1.8 m; the width from a workbench to the wall is generally 1.2~1.5 m; the width of the passageway between a workbench and instruments and equipment should generally not be less than 1.8 m. This is shown in Fig. 4-14.

Fig. 4-14 Schematic Diagram of Workbench Spacing

6. Spacing Between Instruments and Equipment

6.1 The passageway width between two pieces of instruments and equipment is recommended to be 2~2.5 m; the width between instruments and equipment and a workbench is recommended to be not less than 1.8 m; the width between instruments and equipment and the wall is recommended to be 1.8 m. This is shown in Fig. 4-15. Fig. 4-15 Schematic Diagram of Spacing Between Instruments and Equipment

6.2 The distance from the back and sides of a biosafety cabinet to the wall should preferably maintain a maintenance distance of not less than 15~30 cm, and a space of not less than 30 cm should also be left at the top. The recommended minimum space for a biosafety cabinet placed side-on to the door is 1 m; the minimum distance when placed diagonally to the door is 1.8 m; the minimum distance for a person operating with their back to the door is 1.5 m.

7. Space Standards for Public Passageways

If rooms are arranged on one side of a public passageway in the clean area, the minimum clear width should not be less than 1.30 m; for a single passageway with rooms arranged on both sides, the minimum clear width should not be less than 1.60 m. If rooms are arranged on one side of a public passageway in the contaminated area, the minimum clear width should not be less than 1.50 m, and with rooms arranged on both sides, the minimum clear width should not be less than 1.80 m. This is shown in Fig. 4-16.

Fig. 4-16 Biosafety Cabinet Placement Diagram

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