Section 2 Design Requirements for Each Area of Intelligent Medical Laboratories

I. Design Requirements for the Clean Area

The clean area is the area used for office activities, study, and rest of laboratory personnel. It should be established as an independent area, separated from the semi-contaminated/buffer area and the contaminated area. The clean area should be planned rationally according to the overall layout of the laboratory, so that it is convenient for work without mutual interference.

1. Layout of the Meeting Room and Training Room

The meeting room is a dedicated room specifically for medical laboratory technicians or office staff to hold meetings, discussions, or exchange knowledge. A meeting room is generally equipped with a conference table, projection equipment, drinking-water equipment, and so on. In addition to providing a comfortable environment for participants, a well-conceived meeting room design and plan should, more importantly, give attendees a sense of presence so as to achieve effective communication and exchange.

As medical laboratories impose ever-higher requirements on the competence of technicians, the training room must, in terms of location, acoustics, lighting, environment, and many other aspects, prevent both trainees and instructors from being disturbed, enabling them to remain fully engaged throughout the session; this is the single most important principle. This is shown in Fig. 4-17 and Fig. 4-18.

Fig. 4-17 Meeting room

Fig. 4-18 Rendering of the training room

2. Layout of the Director's Office

The director's office is generally designed as a relatively independent space, including an office desk and chair, document cabinets, a handwashing sink, and so on. This is shown in Fig. 4-19.

Fig. 4-19 Director's office

3. Layout of the Reference/Document Room

For the reference/document room, a reasonable number of document cabinets should be provided mainly according to the document storage requirements. In principle, the document cabinets should be placed against the walls and must not block the light.

4. Duty Room

4.1 Layout of the Duty Room

The duty room should be located as close to the waiting area as possible. If it is far from the waiting area, a video doorbell switch connected to the duty room should be installed at the sample delivery window. Duty rooms should be provided separately for men and women. Where conditions permit, a restroom should be provided inside the duty room for the convenience of duty personnel for washing and showering.

4.2 Design and Finishing of the Duty Room

4.2.1 Necessary sleeping facilities and clothing storage lockers shall be provided.

4.2.2 Closed-circuit television signal and network signal shall be designed so that a television set can be installed.

4.2.3 There is no specific grade requirement for finishing; brick walls plastered and coated with latex paint are permitted for wall materials.

5. Design and Finishing of the Clean Area and the Waiting Hall

There is no specific grade requirement for the finishing of the clean area, and the choice of finishing materials is relatively diverse, but the overall finishing style should be simple, dignified, and tasteful. This is shown in Fig. 4-20, Fig. 4-21, Fig. 4-22, and Fig. 4-23.

Fig. 4-20 Lobby rendering I

Fig. 4-21 Lobby rendering II

Fig. 4-22 Lobby rendering III

Fig. 4-23 Lobby rendering IV

II. Design Requirements for the Semi-Contaminated/Buffer Area

The semi-contaminated/buffer area is the buffer zone between the clean area and the contaminated area. Staff entering the laboratory must pass through the semi-contaminated/buffer area before they can enter the laboratory.

1. Layout of the Locker/Changing Room

The locker/changing room should be established as an independent area, separated from other laboratories, with an access-control system installed at the entrance so that non-staff may not enter. It is the area that staff must pass through from the public area into the laboratory; staff must change their clothing in the locker room before entering the laboratory, and it belongs to the semi-contaminated/buffer area. This is shown in Fig. 4-24.

Fig. 4-24 Floor layout plan of the locker/changing room

2. Design and Finishing of the Locker/Changing Room

2.1 Lockers shall be provided according to the number of laboratory personnel, and a handwashing sink shall be installed.

2.2 Physical partitions shall be provided between the locker room and the clean area and between the locker room and the laboratory area.

2.3 There is no specific grade requirement for the finishing of the locker room; brick walls plastered and coated with latex paint are permitted for wall materials.

Fig. 4-25 Locker/changing room

III. Design Requirements for the Contaminated Area

1. Washing and Decontamination Room

The washing and decontamination room is used for washing glassware and utensils and for sterilizing infectious laboratory waste. It shall be equipped with a washing bench, utensil racks, an eyewash station, a drying oven, a high-pressure autoclave, and so on. Multiple large sinks may be selected for the washing bench to facilitate washing; a draining rack on the washing bench facilitates air-drying of utensils. The washing and decontamination room is a dedicated room used for sterilizing and disinfecting part of the medical apparatus and contaminants of the laboratory. In the overall planning and layout of the laboratory, the washing and decontamination room must be located close to the dirty (waste) elevator, so as to facilitate the outward transport of medical waste after it has been disinfected in the washing and decontamination room. Where it is inconvenient to open a door in the direction facing the dirty elevator, a large pass-through box may be used to transport medical waste outward. This is shown in Fig. 4-26.

Fig. 4-26 Floor layout plan of the washing and decontamination room

2. Combined-Mode Laboratory (Clinical Chemistry and Immunology Laboratory)

2.1 Floor Layout of the Clinical Chemistry and Immunology Laboratory

The clinical chemistry and immunology laboratory shall include the collection and receiving of blood and body fluids, the processing of blood specimens and body-fluid specimens, and the clinical examination, biochemistry, and immunology experimental areas. Blood collection includes blood collection (blood drawing) and specimen receiving; a blood collection window and a specimen receiving window shall be provided, and a separate blood-drawing room may also be provided. In setting up the clinical examination, biochemistry, and immunology experimental areas, consideration shall be given to the rationality of the provision and quantity of laboratory benches and floor-standing instruments, so that the usable-area ratio is reasonable and the arrangement better conforms to the workflow of the staff. This is shown in Fig. 4-27, Fig. 4-28, and Fig. 4-29.

Fig. 4-27 Floor layout plan of the clinical chemistry and immunology laboratory

Fig. 4-28 Floor layout plan of the clinical chemistry and immunology laboratory (assembly line)

Fig. 4-29 Rendering of the biochemistry assembly line

2.2 Design and Finishing of the Clinical Chemistry and Immunology Laboratory

2.2.1 Sufficient space must be provided for the safe operation, cleaning, and maintenance of the laboratory.

2.2.2 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant.

2.2.3 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

2.2.4 The laboratory must be provided with a handwashing sink and an eyewash station. Emergency shower facilities shall be installed at suitable locations.

2.2.5 There is no specific grade requirement for finishing; brick walls plastered and coated with latex paint are permitted for wall materials.

2.2.6 The floor may be laid with PVC sheet flooring or other materials.

2.2.7 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating.

2.2.8 If the clinical chemistry and immunology laboratory needs a sample receiving window, anti-theft security measures must be considered, and an anti-theft rolling shutter or other anti-theft measures shall be provided.

2.2.9 A sample centrifugation room with full exhaust function or a centrifuge exhaust device shall be provided.

Fig. 4-30 Rendering of the clinical chemistry and immunology laboratory I

Fig. 4-31 Rendering of the clinical chemistry and immunology laboratory II

Fig. 4-32 Clinical chemistry and immunology laboratory

2.3 Instruments and Equipment of the Clinical Chemistry and Immunology Laboratory

Commonly used equipment includes urine analyzers, urine sediment analyzers, fully automatic chemiluminescence analyzers, fully automatic biochemistry analyzers, electrolyte analyzers, blood gas analyzers, specific protein analyzers, glycated hemoglobin analyzers, trace element analyzers, water purification equipment, fully automatic hematology analyzers, hemorheology analyzers, platelet aggregation analyzers, coagulation analyzers, CRP analyzers, erythrocyte sedimentation rate (ESR) analyzers, fully automatic enzyme immunoassay systems, and medical microscopes.

Auxiliary equipment includes large-capacity horizontal centrifuges, computers, constant-temperature water baths, and refrigerators.

Shared equipment includes electronic balances.

3. Emergency Laboratory

3.1 Floor Layout of the Emergency Laboratory

In principle, the emergency laboratory shall be located in the emergency department. The emergency laboratory shall include changing, living/rest, and work areas. The emergency laboratory performs almost all commonly used emergency clinical test items—complete blood count, routine urinalysis, routine stool examination, coagulation function tests, dry biochemistry testing, cardiac marker testing, and so on. It undertakes not only the routine emergency test items but also expedited testing for ward patients; therefore, its independent floor space should reach about 100 m². The emergency laboratory should be located immediately adjacent to the waiting area; since samples are transferred between the waiting area and the emergency laboratory through a sample receiving window, a sample receiving window must be provided. This is shown in Fig. 4-33.

Fig. 4-33 Floor layout plan of the emergency laboratory

3.2 Design and Finishing of the Emergency Laboratory

See 2.2 Design and finishing of the clinical chemistry and immunology laboratory for details.

Fig. 4-34 Rendering of the emergency laboratory

3.3 Instruments and Equipment of the Emergency Laboratory

Commonly used equipment includes fully automatic biochemistry analyzers or dry biochemistry analyzers, fully automatic blood gas analyzers, fully automatic hematology analyzers, fully automatic urine analyzers, fully automatic chemiluminescence analyzers, and microscopes.

Auxiliary equipment includes ESR analyzers, CRP analyzers, centrifuges, refrigerators, water baths, PCT detectors, and computers.

3.4 Placement of Instruments in the Emergency Laboratory

The instruments in the emergency laboratory are arranged mainly according to the area and orientation of the room. The following instrument layout diagram is provided only as a reference for designers. This is shown in Fig. 4-35.

Fig. 4-35 Instrument layout diagram of the emergency laboratory

4. Routine Clinical Examination Laboratory

4.1 Floor Layout of the Routine Clinical Examination Laboratory

The routine clinical examination laboratory shall include three areas: blood collection, blood testing, and body-fluid testing. It shall be located immediately adjacent to the waiting area; since samples are transferred between the waiting area and the routine examination laboratory through a sample receiving window, sample collection/receiving windows must be provided, separated into a blood collection window and a body-fluid receiving window, and the laboratory shall be established as an independent room. Because the body-fluid area performs tests such as routine urinalysis and routine stool examination, the odor there is relatively strong, so a fume hood or an exhaust hood must be provided. This is shown in Fig. 4-36.

Fig. 4-36 Floor layout plan of the routine clinical examination laboratory

4.2 Design and Finishing of the Routine Clinical Examination Laboratory

See 2.2 Design and finishing of the clinical chemistry and immunology laboratory for details.

4.3 Instruments and Equipment of the Routine Clinical Examination Laboratory

Commonly used equipment includes urine analyzers, urine sediment analyzers, medical microscopes, CRP analyzers, fully automatic hematology analyzers, hemorheology analyzers, fully automatic coagulometers, ESR analyzers, water baths, and so on.

Auxiliary equipment includes horizontal centrifuges, refrigerators, fume hoods, and computers.

4.4 Placement of Instruments in the Routine Clinical Examination Laboratory

The instruments in the routine clinical examination laboratory are arranged mainly according to the area and orientation of the laboratory. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-37.

01 Centrifuge 02 Microscope 03 Fully automatic hematology analyzer 04 Hemorheology analyzer 05 Fully automatic coagulometer 06 Water bath

07 ESR analyzer 08 CRP analyzer 09 Urine analyzer 10 Urine sediment analyzer 11 Computer 12 Refrigerator 13 Fume hood

Fig. 4-37 Instrument layout diagram of the routine clinical examination laboratory

5. Biochemistry Laboratory

5.1 Floor Layout of the Biochemistry Laboratory

In setting up the biochemistry laboratory, consideration shall be given to the rationality of the provision and quantity of side benches and floor-standing instruments, so that the arrangement better conforms to the workflow of the staff. This is shown in Fig. 4-38.

Fig. 4-38 Floor layout plan of the biochemistry laboratory

5.2 Design and Finishing of the Biochemistry Laboratory

See 2.2 Design and finishing of the clinical chemistry and immunology laboratory for details.

Fig. 4-39 Rendering of the biochemistry laboratory

5.3 Instruments and Equipment of the Biochemistry Laboratory

Commonly used equipment includes fully automatic biochemistry analyzers or assembly lines, electrolyte analyzers, blood gas analyzers, specific protein analyzers, glycated hemoglobin analyzers, trace element analyzers, and hemorheology analyzers.

Auxiliary equipment includes large-capacity horizontal centrifuges, computers, constant-temperature water baths, and refrigerators.

Shared equipment includes electronic balances, water purification equipment, UPS power supplies, and so on.

5.4 Placement of Instruments in the Biochemistry Laboratory

The instruments in the biochemistry laboratory are arranged mainly according to the area, orientation, and workflow of the laboratory. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-40.

01 Fully automatic biochemistry analyzer 02 Electrolyte analyzer 03 Blood gas analyzer 04 Specific protein analyzer 05 Glycated hemoglobin analyzer 06 Trace element analyzer 07 Refrigerator 08 Water purification equipment 09 Constant-temperature water bath 10 Large-capacity horizontal centrifuge 11 Electronic balance 12 Computer

Fig. 4-40 Instrument layout diagram of the biochemistry laboratory

6. Immunology Laboratory

6.1 Floor Layout of the Immunology Laboratory

The location and area shall be determined according to the number of personnel, the number of instruments and equipment, and the workload, so that the workflow is rational, safe, and efficient and convenient for work. This is shown in Fig. 4-41.

Fig. 4-41 Floor layout plan of the immunology laboratory

6.2 Design and Finishing of the Immunology Laboratory

See 2.2 Design and finishing of the clinical chemistry and immunology laboratory for details.

Fig. 4-42 Rendering of the immunology laboratory

6.3 Instruments and Equipment of the Immunology Laboratory

Commonly used equipment includes microplate readers, plate washers, biosafety cabinets, fully automatic chemiluminescence analyzers, fully automatic enzyme immunoassay analyzers, and so on.

Auxiliary equipment includes large-capacity horizontal centrifuges, high-pressure sterilizers (autoclaves), constant-temperature water baths, pipettors (samplers), refrigerators, computers, UPS power supplies, and so on.

Optional equipment includes fluorescence microscopes.

6.4 Placement of Instruments in the Immunology Laboratory

The instruments in the immunology laboratory are arranged mainly according to the area of the laboratory, the number of instruments and equipment, and the workflow. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-43.

Fig. 4-43 Instrument layout diagram of the immunology laboratory

7. Sputum Examination Laboratory

7.1 Floor Layout of the Sputum Examination Laboratory

Sputum examination and sputum culture are the principal methods for detecting patients with infectious pulmonary tuberculosis. The laboratory shall have safety equipment and complete experimental facilities; the laboratory environment shall be clean, sanitary, quiet, and free of contamination. Safety management measures and alarm, emergency response, and first-aid facilities shall be available. Where the sputum examination room is adjacent to a public area of the laboratory, an independent specimen delivery corridor shall be provided between the sputum examination room and the public area for the delivery of specimens. This is shown in Fig. 4-44.

7.2 Design and Finishing of the Sputum Examination Laboratory

7.2.1 In designing the laboratory space, consideration shall be given to the need to provide or reserve sufficient experimental area space for the safe operation, cleaning, and maintenance of the laboratory.

7.2.2 Laboratory bench tops shall be waterproof and resistant to disinfectants, acids, alkalis, and organic solvents.
7.2.3 The laboratory must be provided with a handwashing sink and an eyewash station.

7.2.4 The laboratory walls, ceilings, and floors shall be smooth, easy to clean, leakproof, and resistant to corrosion by chemicals and disinfectants; the floors shall be slip resistant.

7.2.5 Ultraviolet germicidal lamps must be installed, with a mounting height between 1.8 and 2.1 m.

7.2.6 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating; automatic door closers are preferably installed.

7.2.7 The laboratory work area shall be designed with negative pressure and shall be provided with a buffer area.

7.3 Instruments and Equipment of the Sputum Examination Laboratory

Commonly used equipment includes microscopes and biosafety cabinets.

Auxiliary equipment includes computers.

7.4 Placement of Instruments in the Sputum Examination Laboratory

The instruments in the sputum examination laboratory shall be arranged on the principles of safety, efficiency, and convenience for work. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-45.

Public corridor

Fig. 4-44 Floor layout plan of the sputum examination laboratory

Fig. 4-45 Instrument layout diagram of the sputum examination laboratory

8. Radioimmunoassay Laboratory

8.1 Floor Layout of the Radioimmunoassay Laboratory

The radioimmunoassay laboratory is one of the principal laboratories of a hospital. The radioimmunoassay laboratory shall be designed as an independent room. This is shown in Fig. 4-46.

8.2 Design and Finishing of the Radioimmunoassay Laboratory

8.2.1 Sufficient space and facilities shall be provided for the safe handling and storage of solvents and radioactive substances, and radiation facilities that ensure safety shall be available.

8.2.2 Laboratory bench tops shall be waterproof and resistant to disinfectants, acids, alkalis, organic solvents, and moderate heat.

8.2.3 The laboratory must be provided with a handwashing sink, preferably installed at the exit.

8.2.4 The laboratory walls, ceilings, and floors shall be smooth, easy to clean, leakproof, and resistant to corrosion by chemicals and disinfectants; the floors shall be slip resistant. Where necessary, lead plate shielding shall be added.

8.2.5 The laboratory walls, ceilings, and floors shall be flat, easy to clean, impermeable to water, and resistant to corrosion by chemicals and disinfectants. It is recommended that color steel plate partitions be used for the partition walls, with all internal corners transitioned with curved (rounded) trim. It is recommended that a color steel plate suspended ceiling be used. The floor shall be slip resistant, leakproof, seamless, smooth, and clean, and PVC flooring is recommended.

8.2.6 Professional lead-lined doors shall be used for laboratory doors. A red warning light shall be installed in the technician operating area; the red warning light illuminates when the lead-lined door is not closed.

Fig. 4-46 Floor layout plan of the radioimmunoassay laboratory

Fig. 4-47 Radioimmunoassay laboratory

8.3 Instruments and Equipment of the Radioimmunoassay Laboratory

Commonly used equipment includes radioimmunoassay analyzers.

Auxiliary equipment includes centrifuges, water baths, refrigerators, and computers.

8.4 Placement of Instruments in the Radioimmunoassay Laboratory

The instruments in the radioimmunoassay laboratory shall be arranged on the principles of safety, efficiency, and convenience for work. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-48.

9. Flow Cytometry Room

9.1 Floor Layout of the Flow Cytometry Room

The flow cytometry room shall be designed as an independent room, with no specific requirement for its location. The flow cytometer is a highly advanced analytical instrument that closely integrates fluid jet technology, laser technology, air technology, (gamma)-ray energy spectrometry, and computer technology with a micro-spectrofluorophotometer. By measuring the scattered light and labeled fluorescence intensity of cells and other biological particles, it rapidly analyzes the physical or chemical properties of particles and can also sort and collect cells.

9.2 Design and Finishing of the Flow Cytometry Room

9.2.1 In designing the laboratory space, consideration shall be given to the need to provide or reserve sufficient laboratory space for the safe operation, cleaning, and maintenance of the laboratory.

9.2.2 Wall plastering shall meet the high-grade plastering standard. After plastering, the walls shall be coated with a paint finish; the coating selected shall be flame retardant, non-cracking, smooth surfaced, wash resistant, and not prone to absorbing moisture, deteriorating, or growing mold.

9.2.3 The laboratory must be provided with a handwashing sink, preferably installed at the exit.

9.2.4 The laboratory walls, ceilings, and floors shall be smooth, easy to clean, leakproof, and resistant to corrosion by chemicals and disinfectants; the floors shall be slip resistant.

9.2.5 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating; automatic door closers are preferably installed.

Fig. 4-48 Instrument layout diagram of the radioimmunoassay laboratory

Fig. 4-49 Instrument layout diagram of the flow cytometry room

9.3 Instruments and Equipment of the Flow Cytometry Room

Commonly used equipment includes flow cytometers and biosafety cabinets.

Auxiliary equipment includes constant-temperature water tanks, centrifuges, refrigerators, pipettors (samplers), and computers.

9.4 Placement of Instruments in the Flow Cytometry Room

The instruments in the flow cytometry room shall be arranged in accordance with the principles of safety, efficiency, a rational workflow, and convenience for work. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-49.

10. Trace Element Room

10.1 Floor Layout of the Trace Element Room

The trace element room shall be planned at the design stage according to the scale and layout of the laboratory as a whole. This is shown in Fig. 4-50.

10.2 Design and Finishing of the Trace Element Room

10.2.1 In designing the laboratory space, consideration shall be given to the need to provide or reserve sufficient laboratory space for the safe operation, cleaning, and maintenance of the laboratory.

10.2.2 Laboratory bench tops shall be waterproof and resistant to disinfectants, acids, alkalis, and organic solvents.

10.2.3 The laboratory must be provided with a handwashing sink at the entrance.

10.2.4 The laboratory walls, ceilings, and floors shall be smooth, easy to clean, leakproof, and resistant to corrosion by chemicals and disinfectants; the floors shall be slip resistant.

10.2.5 Laboratory doors shall have observation windows, and automatic door closers shall be installed.

10.2.6 An exhaust device must be installed so as to promptly remove irritating gases.

10.3 Instruments and Equipment of the Trace Element Room

Commonly used equipment includes trace element analyzers.

Auxiliary equipment includes refrigerators, fume hoods, and computers.

Optional equipment includes atomic absorption spectrometers.

10.4 Placement of Instruments in the Trace Element Room

The instruments in the trace element room shall be arranged in accordance with the principles of safety, efficiency, a rational workflow, and convenience for work. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-51.

Fig. 4-50 Floor layout plan of the trace element room

Fig. 4-51 Instrument layout diagram of the trace element room

11. HIV Screening Laboratory

11.1 Main Work Content of the HIV Screening Laboratory

Laboratory determination of human immunodeficiency virus (HIV) or its corresponding markers is performed on human blood, tissue fluid, excreta, tissues, organs, semen, and related blood products, biological tissues, or other items, including the detection of HIV antigens and antibodies.

11.2 Documents Related to the Construction of the HIV Screening Laboratory

According to the Regulations on Biosafety Management of Pathogenic Microorganism Laboratories, human immunodeficiency virus (HIV) is a highly pathogenic microorganism and is listed as a hazard category 2 pathogenic microorganism. To ensure the accuracy and reliability of HIV testing and to guarantee the safety of AIDS testing laboratories, the construction and management of the laboratory must comply with the provisions of the following documents.

11.2.1 National Technical Specifications for AIDS Testing 11.2.2 Medical Laboratories—Safety Requirements 11.2.3 General Requirements for Laboratory Biosafety 11.2.4 Architectural Technical Code for Biosafety Laboratories 11.2.5 Regulations on Biosafety Management of Pathogenic Microorganism Laboratories

11.3 Biosafety Level of the HIV Screening Laboratory

11.3.1 AIDS serological testing (including screening and confirmatory laboratories), immunological testing, and nucleic acid testing shall be performed in AIDS testing laboratories that meet the requirements for a biosafety level II laboratory (BSL-2). The laboratory shall comply with all the requirements for biosafety level II laboratories set out in the General Requirements for Laboratory Biosafety (GB 19489-2008).

11.3.2 HIV isolation, cell culture, and research work shall be carried out in a biosafety level III laboratory.

11.4 Layout of the HIV Screening Laboratory

The HIV screening laboratory shall be provided with a preparation area, a buffer area, and an experimental area, with access control at the entrance. Staff pass from the preparation area into the buffer area for a second change of clothing, and then from the buffer area into the experimental area. Material flow enters and leaves the experimental area directly from the outer corridor through pass-through boxes. An observation window must be provided between the preparation area and the experimental area so that they are transparent to each other. Handwashing facilities must be provided at the exits of both the experimental area and the preparation area; the experimental area must also be provided with an eyewash station. This is shown in Fig. 4-52 and Fig. 4-53.

Fig. 4-52 Floor layout plan of the HIV screening laboratory

Fig. 4-53 Aerial view of the HIV screening laboratory

11.5 Design and Finishing of the HIV Screening Laboratory

11.5.1 The total area of the laboratory shall be (geq 30text{ m}^2). The walls, ceilings, and floors of the laboratory shall be flat, easy to clean, impermeable to water, and resistant to corrosion by chemicals and disinfectants. The floor shall be slip resistant and leakproof.

11.5.2 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant.

11.5.3 Laboratory benches shall be sturdy; a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

11.5.4 Adequate work lighting shall be ensured inside the laboratory, while unnecessary strong light shall also be avoided. Cleanroom-type luminaires shall be selected, achieving the characteristics of being easy to clean and not accumulating dust.

11.5.5 Laboratory doors shall be cleanroom doors, shall have observation windows and automatic door closers, and laboratory doors must not open directly opposite one another but must be opened diagonally offset. There shall be a design that prevents arthropods and rodents from entering. The doors shall bear compliant BSL-2 laboratory danger signs and biohazard warning signs.

11.5.6 Each subarea of the laboratory shall be provided with a non-contact faucet and a handwashing sink (the basin shall be more than 30 cm deep), preferably located near the exit. The experimental area shall have an eyewash device and, where necessary, an emergency shower device.

11.5.7 Computers and printers shall be located in the clean area, and all report forms shall be kept clean.

11.5.8 The laboratory exits shall bear signs that can be clearly identified in the dark.

11.5.9 There shall be a reliable power supply and emergency lighting. Each room must be fitted with an ultraviolet germicidal lamp, with a mounting height between 1.8 and 2.1 m.

Fig. 4-54 Preparation area of the HIV screening laboratory

Fig. 4-55 Experimental area of the HIV screening laboratory

11.6 Instruments and Equipment of the HIV Screening Laboratory

Commonly used equipment includes microplate readers, plate washers, and chemiluminescence analyzers.

Auxiliary equipment includes centrifuges, pipettors (samplers), constant-temperature water tanks, internal-circulation high-pressure steam sterilizers (autoclaves), refrigerators, biosafety cabinets, and computers.

11.7 Placement of Instruments in the HIV Screening Laboratory

The instruments in the HIV screening laboratory shall be arranged in accordance with the principles of safety, efficiency, a rational workflow, and convenience for work. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-56.

Fig. 4-56 Instrument layout diagram of the HIV screening laboratory

11.8 Ventilation and Air-Conditioning System

An independent laboratory exhaust system shall be installed, and it shall be ensured that, while the laboratory is operating, airflow moves from low-risk areas toward high-risk areas. The arrangement of supply-air and exhaust-air outlets in the rooms of the laboratory protection zone shall conform to the principle of directional airflow, and the supply and exhaust air shall not interfere with the normal functioning of other equipment (such as Class II biosafety cabinets).

11.9 Lighting System

The illuminance in the core workroom of the laboratory shall be no less than 350 lx, and the illuminance in other areas shall be no less than 200 lx; an emergency lighting system with a duration of no less than 30 min shall be provided.

11.10 Waste Disposal and Disinfection

All waste coming out of the AIDS laboratory shall be regarded as infectious waste and shall be treated and discarded only after high-pressure sterilization (autoclaving).

12. PCR Laboratory

The clinical gene amplification testing laboratory is also known as the PCR laboratory. Its characteristic feature is that it can massively amplify minute amounts of DNA and RNA. PCR is a routine method in molecular biology research and experimentation and is widely applied across all fields of biology, for example: testing for AIDS, hepatitis B, hepatitis C, and avian epidemics; detection of oncogenes; DNA fingerprinting, individual identification, paternity testing, and forensic physical evidence; and detection of genetically modified crops and genetically modified microorganisms.

12.1 Floor Layout of the PCR Laboratory

The PCR laboratory may be designed with different zoning according to different operating platforms, and it may even be sufficient to provide just one room, with one instrument able to accomplish the process from preparation → amplification → analysis. In principle, the PCR laboratory is divided into four separate work areas, namely the reagent storage area, the sample processing area, the gene amplification area, and the amplification product analysis area. The various areas must be completely separated from one another, with no air circulation between them. Reagents, samples, and experimental materials may flow only in a single direction, namely from the reagent storage area → sample preparation area → gene amplification area → product analysis area, and must not flow in the reverse direction. The laboratory airflow shall likewise flow from the first area toward the latter areas and must not flow in reverse. Each work area shall be provided with an airlock (buffer room), and interlocking devices should be installed between the workrooms and the buffer rooms. Nucleic acid testing work areas with different functions shall be separated, independent workrooms with clearly visible signs, and the areas must not connect directly to one another. Each workroom shall be fitted with a pass-through box for materials. The top of each work area shall be fitted with ultraviolet lamps, at a quantity of one 40 W ultraviolet lamp per 20 (text{m}^2); at the same time, movable ultraviolet lamps shall be provided.

The more ideal layout pattern for the laboratory is to have a dedicated corridor, with the reagent storage area, sample preparation area, gene amplification area, and product analysis area arranged together in a well-regulated manner; each area is provided with a buffer area that can be used for changing work clothes and work shoes, and an ultraviolet lamp shall be fitted overhead. The work areas of the reagent storage area and the sample preparation area are at relative positive pressure; their buffer areas are at relative negative pressure. The work areas of the amplification area and the amplification product analysis area are at relative negative pressure, and their buffer areas are at relative positive pressure. This pressure differential can be regulated through supply- and exhaust-air devices. The doors inside the buffer room leading to the inner laboratory and to the corridor must be set diagonally opposite rather than directly facing each other, and interlocking devices may be installed so that when one door is open the other door must be in the closed state, preventing the situation in which both doors are open at the same time. Every area must be clearly marked, and work proceeds in a single flow direction according to the reagent storage area, sample preparation area, gene amplification area, and product analysis area. This is shown in Fig. 4-57, Fig. 4-58, Fig. 4-59, Fig. 4-60, Fig. 4-61, and Fig. 4-62. If the above pattern cannot be achieved, the following basic requirements must be met:

12.1.1 If a real-time fluorescence quantitative PCR amplification instrument is used, the amplification area and the product analysis area may be combined, so that the whole PCR room is divided into three areas, namely reagent preparation area → specimen preparation area → amplification analysis area. If a fully automatic integrated testing system from sample processing through amplification analysis is used, the latter two areas can in turn be combined, so that the whole PCR room is divided into two areas, namely the reagent storage area and the gene testing area.

12.1.2 Each area is completely independent, and pass-through boxes for materials are installed between the work areas.

12.1.3 Every area must have an independent buffer room for changing work clothes and shoes and for ensuring that it remains in a relatively separated state from the workroom at all times.

12.1.4 Both the work areas and the buffer rooms shall be fitted with ventilation (air exchange) devices so as to regulate airflow pressure.

12.1.5 The supply- and exhaust-air ducts between the various areas must be independently installed and must not be interconnected.

Fig. 4-57 Floor layout plan of the PCR laboratory (six rooms)

Fig. 4-58 Floor layout plan of the PCR laboratory (five rooms)

Fig. 4-59 Floor layout plan of the PCR laboratory (four rooms)

Fig. 4-60 Top view of the PCR laboratory (four rooms)

Fig. 4-61 Floor layout plan of the PCR laboratory (three rooms)

Fig. 4-62 Floor layout plan of the gene sequencing laboratory

12.2 Functions and Principal Equipment of Each Area

12.2.1 Reagent storage area: The principal function of this experimental area is the storage and preparation of reagents. Reagents and materials used for sample preparation shall be delivered directly to this area and must not pass through other areas. Raw reagent materials must be stored in this area and prepared within this area into the required application reagents; the principal equipment in this area is a low-temperature freezer.

12.2.2 Specimen preparation area: The operations mainly performed in this area are the preservation of samples and the extraction, storage, and purification of nucleic acids (RNA, DNA). The equipment in this area mainly includes biosafety cabinets, centrifuges, low-temperature high-speed centrifuges, water baths, refrigerators, micro-oscillators, and so on.

12.2.3 Gene amplification area: The operation mainly performed in this area is DNA amplification, and it now simultaneously possesses the function of amplification product analysis. The principal equipment includes a nucleic acid amplification instrument and a computer control system.

Fig. 4-63 Dedicated corridor of the PCR laboratory

Fig. 4-64 Buffer area of the PCR laboratory

Fig. 4-65 Work area of the PCR laboratory

Fig. 4-66 Work area of the PCR laboratory

Fig. 4-67 Work area of the PCR laboratory

Fig. 4-68 Work area of the PCR laboratory (pass-through box)

12.2.4 Product analysis area: The operation mainly performed in this area is the determination of amplified fragments.

12.3 Design of the Laboratory Air-Conditioning and Ventilation System and Pressure Control

A single-flow-direction pattern of material flow, personnel flow, and airflow shall be formed between the various areas, creating a single-flow-direction protective barrier and avoiding mutual interference between laboratories.

The PCR laboratory has no strict purification requirement; however, to avoid the possibility of cross-contamination between the various experimental areas, an air distribution pattern of full supply and full exhaust should be adopted. At the same time, the ratio of supply air to exhaust air must be strictly controlled so as to guarantee the pressure requirements of each laboratory.

12.4 Laboratory Finishing

12.4.1 The laboratory walls, including the ceiling, shall be structurally sturdy and have good airtightness; all internal corners shall be transitioned with curved (rounded) trim. The inner wall surfaces shall be smooth, non-adsorbent, corrosion resistant, and easy to clean and disinfect. It is recommended that color steel plates be used for the walls and suspended ceiling.

12.4.2 The floor material shall meet the requirements of being seamless, leakproof, smooth, and corrosion resistant.

12.4.3 Cleanroom-type luminaires shall be selected, achieving the characteristics of being easy to clean and not accumulating dust.

12.4.4 An ultraviolet lamp is installed inside the pass-through box for disinfection purposes.

12.4.5 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant. Epoxy resin bench tops are generally used.

12.4.6 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

12.4.7 Laboratory doors shall be cleanroom doors, shall have observation windows and automatic door closers, and laboratory doors must not open opposite one another but must open in a staggered arrangement. This is shown in Fig. 4-69.

12.4.8 There shall be a reliable power supply and emergency lighting. Each room must be fitted with an ultraviolet germicidal lamp, with a mounting height between 1.8 and 2.1 m.

Fig. 4-69 Door of the PCR laboratory

12.5 Instruments and Equipment of the PCR Laboratory

Commonly used equipment includes gene amplification instruments (thermal cyclers), biosafety cabinets, pipettors (samplers), oscillators, high-speed centrifuges, movable ultraviolet lamps, constant-temperature water baths, and constant-temperature metal baths.

Auxiliary equipment includes electronic balances, refrigerators, and computers.

Optional equipment includes microplate readers and plate washers.

12.6 Placement of Instruments in the PCR Laboratory

The instruments in the PCR laboratory shall be arranged in accordance with the principles of safety, efficiency, contamination prevention, a rational workflow, and convenience for work. The following instrument layout diagrams are provided only as a reference for laboratory personnel. This is shown in Fig. 4-70 and Fig. 4-71.

Fig. 4-70 Instrument layout plan of the PCR laboratory (three rooms)

Fig. 4-71 Instrument layout diagram of the PCR laboratory (four rooms)

12.7 Issues for Attention

12.7.1 The size of each area shall be determined according to the quantity of instruments and equipment and the work content. In general, the reagent storage area is required to be the smallest, the sample processing area the largest, and the sizes of the gene amplification area and the amplification product analysis area intermediate between the two.

12.7.2 Emergency eyewash stations shall be set up in the reagent preparation area and the specimen preparation area against unexpected needs.

12.7.3 The cleanliness level of the PCR laboratory may be designed according to the user's actual situation and the level of capital investment.

13. Microbiology Laboratory

As an important department of the clinical laboratory, the microbiology laboratory is a key unit for biosafety control. Precautions against biological hazards need to receive greater emphasis than in other laboratories. At the same time, the pathogenic hazards of the microbiology laboratory can easily affect other laboratories; therefore, its design must strictly follow the relevant management measures.

13.1 Floor Layout of the Microbiology Laboratory

The microbiology laboratory shall be established as an independent area, separated from other laboratories, with access control at the entrance so that non-staff may not enter. The rooms shall be rationally laid out according to their work content, so that they are convenient for work without mutual interference. A centralized changing room shall be provided at the entrance, and multiple culture rooms may be provided according to the different culture conditions and types (such as fungal culture, bacterial culture, and so on). This is shown in Fig. 4-72, Fig. 4-73, and Fig. 4-74.

Fig. 4-72 Floor layout plan of the microbiology laboratory

Fig. 4-73 Experimental area of the microbiology laboratory

Fig. 4-74 Preparation area of the microbiology laboratory

Clean laboratory: It forms its own zone, placed in a corner at the edge of the laboratory. Rooms with cleanliness requirements are placed in locations with little personnel disturbance, while auxiliary rooms are placed on the outside. Taking the microbiological experimental workflow into account, the identification room is placed adjacent to the culture room and the washing and decontamination room to facilitate the separation of personnel flow and material flow. In the clean laboratory, staff enter the corridor and then the preparation area, and from the preparation area proceed through the locker room and buffer area into the operating area. Material flow is accomplished through pass-through boxes. The exhaust-air outlets are fitted with high-efficiency filters, and the supply-air outlets are fitted with high-efficiency filter plenum boxes. Indoor supply and exhaust air adopt the pattern of supply from above and exhaust from below; the indoor exhaust air is arranged on one side and must not be obstructed. A residual-pressure valve automatically regulates the indoor pressure to maintain a positive-pressure clean state.

Disinfection room: The dimensions of the disinfection room are determined according to the daily workload, with complete water supply and drainage facilities; the floor shall have a good drainage slope and floor drains.

Culture room: Staff enter the preparation area from the corridor and proceed directly from the preparation area into the culture room, which is mainly equipped with various incubators.

13.2 Design and Finishing of the Microbiology Laboratory

13.2.1 Sufficient space must be provided for the safe operation, cleaning, and maintenance of the laboratory.

13.2.2 The laboratory walls, including the ceiling, shall be structurally sturdy and have good airtightness; all internal corners shall be transitioned with curved (rounded) trim. The inner wall surfaces shall be smooth, non-adsorbent, corrosion resistant, and easy to clean and disinfect.

13.2.3 The floor material shall meet the requirements of being seamless, leakproof, smooth, and corrosion resistant.

13.2.4 Cleanroom-type luminaires shall be selected, achieving the characteristics of being easy to clean and not accumulating dust.

13.2.5 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant. Epoxy resin bench tops are generally used.

13.2.6 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

13.2.7 Laboratory doors shall be cleanroom doors, shall have observation windows and automatic door closers, and shall meet the appropriate fire-resistance rating. Laboratory doors must not open directly opposite one another but must open diagonally offset. The main entrance door shall bear a compliant BSL-2 laboratory danger warning sign.

13.2.8 There shall be a reliable power supply and emergency lighting. Each room must be fitted with an ultraviolet germicidal lamp, with a mounting height between 1.8 and 2.1 m.

13.2.9 The design, construction, and installation of equipment shall facilitate operation and be easy to maintain, clean, and decontaminate.

Fig. 4-75 Ultraviolet lamps in the microbiology laboratory

Fig. 4-76 Door of the microbiology laboratory

Fig. 4-77 Partition of the microbiology laboratory

13.3 Instruments and Equipment of the Microbiology Laboratory

Commonly used equipment: incubators, microscopes, biosafety cabinets, fully automatic bacterial identification and analysis systems, and blood culture systems.

Auxiliary equipment includes drying ovens, sterilizers, balances, spectrophotometers, acidometers (pH meters), refrigerators, constant-temperature water baths, centrifuges, microscopic image analysis systems, pipettors (samplers), and computers.

13.4 Placement of Instruments in the Microbiology Laboratory

The instruments in the microbiology laboratory shall be arranged in accordance with the principles of safety, efficiency, a rational workflow, and convenience for work. The following instrument layout diagram is provided only as a reference for laboratory personnel. This is shown in Fig. 4-78.

Fig. 4-78 Instrument layout diagram of the microbiology laboratory

14. Pathology Specimen Receiving Room

14.1 Floor Layout of the Pathology Specimen Receiving Room

The specimen collection/dispatch room shall be located immediately adjacent to the waiting area; since samples are transferred between the waiting area and the specimen receiving room through a sample receiving window, a sample receiving window must be provided, and the room shall be established as an independent room.

14.2 Design and Finishing of the Specimen Receiving Room

14.2.1 The necessary space and facilities shall be provided for specimen registration, barcode scanning, and information entry.

14.2.2 Sufficient space must be provided for the temporary storage of specimens and for safe operation.

14.2.3 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant.

14.2.4 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

14.2.5 A handwashing sink must be provided.

14.2.6 There is no specific grade requirement for finishing; brick walls plastered and coated with latex paint are permitted for wall materials.

Fig. 4-79 Floor layout plan of the specimen receiving room

14.2.7 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating.

14.2.8 An anti-theft rolling shutter or other anti-theft measures shall be provided.

14.2.9 An exhaust device shall be installed above the specimen placement counter.

15. Grossing (Tissue Sampling) Room

15.1 Requirements for Setting Up the Grossing Room

The basic facilities of the grossing room include: a grossing bench with exhaust and rinsing functions, an auxiliary grossing bench, a gross examination (macroscopy) table, various grossing tools, a grossing record desk, networked computers, and so on. In setting up the grossing room, full consideration shall be given to the rationality of the provision and quantity of instruments and grossing benches, so that the usable-area ratio can achieve its due efficiency and conform to the workflow of the staff.

Fig. 4-80 Floor layout plan of the grossing room

15.2 Design and Finishing of the Grossing Room

15.2.1 The laboratory walls, including the ceiling, shall be structurally sturdy and have good airtightness; all internal corners shall be transitioned with curved (rounded) trim. The inner wall surfaces shall be smooth, non-adsorbent, corrosion resistant, and easy to clean and disinfect.

15.2.2 The floor material shall meet the requirements of being seamless, leakproof, smooth, slip resistant, and corrosion resistant.

15.2.3 Cleanroom-type luminaires shall be selected, achieving the characteristics of being easy to clean and not accumulating dust.

15.2.4 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant. Epoxy resin bench tops are generally used.

15.2.5 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

15.2.6 Laboratory doors shall have observation windows.

15.2.7 There shall be a reliable power supply and emergency lighting. Ultraviolet disinfection equipment shall be installed, with germicidal lamps at a mounting height between 1.8 and 2.1 m. There shall be a water supply and drainage system that meets the environmental pollution requirements (including an independent sewage discharge system and a sewage treatment tank).

15.2.8 The installation of equipment shall facilitate operation, maintenance, cleaning, decontamination, and quality testing.

15.2.9 A dedicated fume hood shall be installed so that the harmful waste gases generated during work are carried away through the fume hood rather than being dispersed throughout the laboratory.

16. Pathology Slide Preparation Room

16.1 Basic Facilities of the Slide Preparation Room

The slide preparation room shall be equipped with a paraffin microtome, a freezing microtome (cryostat), a fully automatic tissue dehydrator (processor), a fully automatic stainer, a coverslipper (slide mounting machine), a tissue cassette labeling machine, a slide labeling machine, a tissue embedding machine, disposable blades, a constant-temperature incubator, a drying oven, a refrigerator, and an air conditioner, and shall have toxin-exhausting and ventilation equipment.

16.2 Design and Finishing of the Slide Preparation Room

16.2.1 Sufficient space must be provided for the safe operation, cleaning, and maintenance of the laboratory.

16.2.2 Laboratory bench tops shall be waterproof, corrosion resistant, heat resistant, and flame retardant.

16.2.3 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

16.2.4 The laboratory must be provided with a handwashing sink and an eyewash station.

16.2.5 There is no specific grade requirement for finishing; brick walls plastered and coated with latex paint are permitted for wall materials.

16.2.6 The floor shall be impermeable, slip resistant, and corrosion resistant.

16.2.7 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating.

16.2.8 There shall be a reliable power supply and emergency lighting. Sufficient ultraviolet disinfection equipment shall be installed, with germicidal lamps at a mounting height between 1.8 and 2.1 m. There shall be a water supply and drainage system that meets the environmental pollution requirements (including an independent sewage discharge system).

16.2.9 A dedicated fume hood bench (local ventilation) shall be installed so that the harmful waste gases generated during work are carried away through the fume hood rather than being dispersed throughout the laboratory. At the same time, the laboratory shall also have good ventilation function (whole-room ventilation) capable of promptly discharging harmful waste gases from the laboratory.

Fig. 4-81 Floor layout plan of the slide preparation room

17. Immunohistochemistry Room

17.1 Basic Facilities of the Immunohistochemistry Room

Immunohistochemistry is based on the principle of specific binding between an antigen and its antibody. Through a chemical reaction, a labeled chromogenic reagent (fluorescein, enzyme, metal ion, or isotope) is made to develop color so as to determine the antigen (polypeptide or protein) within tissue cells; the localization, qualitative, and quantitative study thereof is called immunohistochemistry. The immunohistochemistry room shall be equipped with a laboratory bench, a constant-temperature incubator, a drying oven, a refrigerator, a pressure cooker, a microwave oven, and reagent cabinets. Where conditions permit, a fully automatic immunohistochemistry stainer shall be added.

17.2 Design and Finishing of the Immunohistochemistry Room

17.2.1 Sufficient space must be provided for the safe operation, cleaning, and maintenance of the laboratory.

17.2.2 Laboratory bench tops shall be waterproof, corrosion resistant, heat resistant, and resistant to acids and alkalis.

17.2.3 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

Fig. 4-82 Floor layout plan of the immunohistochemistry room

17.2.4 The laboratory must be provided with a handwashing sink, a non-hand-operated faucet, and an eyewash station.

17.2.5 There is no specific grade requirement for finishing; brick walls plastered and coated with latex paint are permitted for wall materials.

17.2.6 The floor shall be impermeable, slip resistant, and corrosion resistant.

17.2.7 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating.

17.2.8 An exhaust device shall be installed.

18. Frozen Section Room

18.1 Basic Facilities of the Frozen Section Room

A frozen section is a method in which tissue is rapidly cooled at low temperature to a certain hardness and then sectioned. Because its preparation process is faster and simpler than that of paraffin sections, it is mostly used for rapid pathological diagnosis during surgery. There are many types of frozen sectioning, including the low-temperature cryostat frozen section method, the carbon dioxide frozen section method, and the methanol circulation refrigeration frozen section method. With the passage of time and the development of science and technology, many of these methods, regarded years ago as important techniques, have gradually been phased out. Of course, some techniques, such as the low-temperature cryostat frozen section method, are currently in favor. Frozen-section pathological diagnosis is of great help and guiding significance for surgical treatment, and the diagnosis must strive to be correct, rapid, and reliable.

18.2 Design and Finishing of the Frozen Section Room

18.2.1 Sufficient space must be provided for the safe operation, cleaning, and maintenance of the laboratory.

18.2.2 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant.

18.2.3 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

18.2.4 The laboratory must be provided with a handwashing sink, a non-hand-operated faucet, and an eyewash station.

18.2.5 There is no specific grade requirement for finishing; brick walls plastered and coated with latex paint are permitted for wall materials.

18.2.6 The floor shall be impermeable, slip resistant, corrosion resistant, and easy to clean.

18.2.7 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating.

18.3 Basic Equipment Configuration of the Frozen Section Room

Commonly used equipment includes a freezing microtome (cryostat), a computer, a fax machine, a staining cabinet, and a grossing bench.

19. Cytology Slide Preparation Room

19.1 Floor Layout of the Cytology Slide Preparation Room

Fig. 4-83 Floor layout plan of the frozen section room

In setting up the cytology slide preparation room, consideration shall be given to the rationality of the provision and quantity of laboratory benches, so that its usable area is reasonable and effective and better conforms to the workflow of the staff.

19.2 Design and Finishing of the Cytology Slide Preparation Room

19.2.1 In designing the laboratory space, consideration shall be given to the need to provide or reserve sufficient laboratory space for the safe operation, cleaning, and maintenance of the laboratory.

19.2.2 Wall plastering shall meet the high-grade plastering standard. After plastering, the walls shall be coated with a paint finish; the coating selected shall be flame retardant, non-cracking, smooth surfaced, wash resistant, and not prone to absorbing moisture, deteriorating, or growing mold.

19.2.3 The laboratory must be provided with a handwashing sink, preferably installed at the exit.

19.2.4 The laboratory walls, ceilings, and floors shall be smooth, easy to clean, leakproof, and resistant to corrosion by chemicals and disinfectants; the floors shall be slip resistant.

19.2.5 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating; automatic door closers are preferably installed.

19.3 Basic Equipment Configuration of the Cytology Slide Preparation Room

Commonly used equipment includes slide preparation machines (cytospin processors), centrifuges, drying ovens, constant-temperature incubators, refrigerators, a TCT reporting system, and specimen storage cabinets.

20. Molecular Pathology Testing Room

20.1 Floor Layout of the Molecular Pathology Testing Room

Molecular pathology includes the use of molecular and genetic methods to diagnose and classify tumors, the design and validation of predictive biomarkers for treatment response and disease progression, individual susceptibility to tumors arising from different genetic constitutions, and the influence of environmental factors and lifestyle on tumor occurrence.

At the design stage, the molecular pathology testing room is classified as a routine department of the department of pathology, and its location shall be planned according to the scale and layout of the laboratory as a whole.

20.2 Design and Finishing of the Molecular Pathology Testing Room

20.2.1 In designing the laboratory space, consideration shall be given to the need to provide or reserve sufficient experimental area space for the safe operation, cleaning, and maintenance of the laboratory.

Fig. 4-84 Floor layout plan of the cytology slide preparation room

Fig. 4-85 Floor layout plan of the molecular testing room

20.2.2 Wall plastering shall meet the high-grade plastering standard. After plastering, the walls shall be coated with a paint finish; the coating selected shall be flame retardant, non-cracking, smooth surfaced, wash resistant, and not prone to absorbing moisture, deteriorating, or growing mold.

20.2.3 The laboratory must be provided with a handwashing sink, preferably installed at the exit.

20.2.4 The laboratory walls, ceilings, and floors shall be smooth, easy to clean, leakproof, and resistant to corrosion by chemicals and disinfectants; the floors shall be slip resistant.

20.2.5 Laboratory doors shall have observation windows, and automatic door closers are preferably installed.

20.3 Basic Equipment Configuration of the Molecular Pathology Testing Room

Commonly used equipment includes a fluorescence microscope imaging analysis system, an in situ hybridization instrument, a bench-top high-speed refrigerated centrifuge, a real-time fluorescence quantitative PCR instrument, and a gene sequencer.

21. Pathology Diagnosis Room

21.1 Floor Layout of the Diagnosis Room

The diagnosis room is one of the principal workplaces of the department of pathology in a hospital and shall be designed as an independent room, belonging to a relatively clean area. In setting up the diagnosis room and determining its area, full consideration shall be given to the number of personnel and the number and locations of workbenches, so that the usable-area ratio can achieve its due efficiency for the convenience of the staff.

Fig. 4-86 Floor layout plan of the diagnosis room

21.2 Design and Finishing of the Diagnosis Room

21.2.1 Sufficient space must be provided for the safe operation, cleaning, and maintenance of the laboratory.

21.2.2 Laboratory bench tops shall be waterproof, corrosion resistant, and heat resistant.

21.2.3 The cabinets in the laboratory benches and the laboratory benches themselves shall be sturdy, and a certain distance shall be maintained between benches, cabinets, and other equipment so as to facilitate cleaning.

21.2.4 The laboratory must be provided with a handwashing sink and fitted with a non-hand-operated handwashing device.

21.2.5 There is no specific grade requirement for finishing; brick walls plastered and coated with latex paint are permitted for wall materials.

21.2.6 The floor shall be impermeable, slip resistant, and corrosion resistant.

21.2.7 Laboratory doors shall have observation windows and shall meet the appropriate fire-resistance rating.

21.3 Basic Equipment Configuration of the Diagnosis Room

Commonly used equipment includes microscopes, image-and-text software, and computers.