1. GBJ 16-87 Code for Fire Protection Design of Buildings

  2. DB 50057-94 Code for Design of Lightning Protection of Buildings

  3. GB 50346-2004 Technical Code for Laboratory Buildings

  4. SN/T 1193-2003 Technical Requirements for Gene Testing Laboratories

  5. GB/T 14925-94 Basic Standards for Laboratory Protection

  6. GB 4792-84 Basic Standards for Radiological Health Protection

  7. GB 8703-88 Regulations on Radiation Protection

  8. GB 8978-1996 Integrated Wastewater Discharge Standard

  9. GB 16297-1996 Integrated Emission Standard of Air Pollutants

Section 2 Design Process for Intelligent Medical Laboratory Construction

The construction of a medical laboratory—whether a new build, expansion, or renovation project—requires comprehensive consideration of the laboratory's overall planning, rational layout and floor-plan design, as well as infrastructure and basic conditions such as power supply, water supply, gas supply, ventilation, air conditioning, air purification, safety measures, and environmental protection. Laboratory construction is therefore a complex systems engineering project that must be completed jointly by architects, project engineers, and the end users. The medical laboratory design process can be divided into three stages: conceptual design, schematic (outline) design, and detailed design.

I. Conceptual Design

In the conceptual design stage, the designer should determine the overall goals and direction of the project, usually involving the following questions.

  1. Overall goals of medical laboratory design: safety, efficiency, and comfort are the three essential elements of an ideal laboratory environment and are also the goals of laboratory construction.

  2. Overall requirements of the laboratory users: explain why the project is being built, what problems it is intended to solve, what the research tasks are, and what the scale of development will be.

  3. Building structure and area: acquire a basic understanding of the building in which the laboratory is located, such as the building structure, the building's orientation, the floor location, and the area the laboratory will occupy.

  4. Location of office areas and laboratory areas: this is the first basic question of laboratory planning to be resolved, and it involves the relationship between the laboratory and other departments on the same floor and on the floors above and below.

  5. Systems engineering involved in the laboratory: laboratory construction is a large and complex project involving many systems, such as air-conditioning systems, ventilation systems, cleanroom systems, wastewater treatment systems, and so on. It must be clarified with the laboratory users which systems the laboratory builder is required to complete, as this affects the project budget estimate.

  6. Estimating the project budget: submit an estimated project cost to the laboratory users or investors.

II. Schematic (Outline) Design

In the schematic design stage, the designer and the users need to communicate and reach consensus on the following issues.

  1. The user issues a design brief (design assignment) to the designer: the user or investor issues a design brief to the designer. Sometimes the user does not have a written design brief, but in the course of communication the user has already conveyed their requirements for the laboratory to the designer in detail.

  2. Number of laboratory staff: the user should provide the relevant data to the designer in the design brief.

  3. Laboratory workflow: the designer should understand this information when communicating with the user, as it will affect the basic planning outcome of the laboratory.

  4. Functions and number of laboratory departments: because laboratories vary in size and functional requirements, there may be some laboratory departments with which the designer is less familiar; the functions of such departments must be clarified with the user. The number of laboratory departments also affects the basic planning of the laboratory.

  5. Dimensions of laboratory modules: an experienced designer is generally well acquainted with conventional laboratory module dimensions. See Chapter 4 of this book, Guidelines for Space Design of Intelligent Medical Laboratories.

  6. Laboratory space standards: an experienced designer is also generally familiar with conventional laboratory space standards. See Chapter 4 of this book, Guidelines for Space Design of Intelligent Medical Laboratories.

  7. Environmental requirements of the laboratory: environmental requirements regarding noise, vibration protection, dust protection, corrosion protection, magnetic protection, and shielding shall comply with relevant national regulations.

  8. Floor plan layout: fully understand the user's planning ideas for the laboratory.

  9. Building layout coordinated with the laboratory modules: understand the other departments on the floors above and below the laboratory. For example, a large clinical chemistry laboratory in the laboratory contains many large, relatively noisy instruments; if the hospital's operating rooms happen to be directly below, the location of the large chemistry laboratory should be reconsidered.

III. Detailed Design

In the detailed design stage, all of the following details will be finalized.

  1. Confirmation of the interior floor plan of the laboratory building: the designer submits the interior planning floor plan of the laboratory to the user.

  2. All interior planning details of the laboratory: see the laboratory design construction drawings.

  3. Laboratory furniture and accessories: produce detailed drawings of laboratory furniture.

  4. Laboratory instruments and equipment: provide the user with a reference layout drawing of laboratory instruments and equipment.

  5. Laboratory systems engineering: supporting drawings for the laboratory's related systems engineering.

  6. Preparation of the complete set of laboratory design construction drawings: provide the user with the laboratory design construction drawings.

  7. Detailed cost report: submit a detailed laboratory project cost budget to the user.

When the above series of processes is applied to actual work, it involves the following detailed content.

When the designer communicates with the hospital or laboratory users, the designer should gain a detailed understanding of their needs. The details of the information to be gathered can be recorded in tabular form as a reference basis for designing the laboratory, as shown in Table 2-1.

Table 2-1 Medical Laboratory Design Task Table

Task Conceptual Design Schematic Design Detailed Design
1. Comparative analysis of existing facilities with similar facilities Yes Yes Yes
2. Interviews with project leader and users Yes Yes Yes
3. Establish space standards Yes Yes Yes
4. List of room types Yes Yes
5. Floor and room plan drawings Yes
6. Determine the area and quantity of each room type Yes Yes Yes
7. List of room performance indicators and data Yes
8. Net building area of the project Yes Yes Yes
9. Gross construction area of the project Yes Yes Yes
10. Describe basic mechanical and electrical piping systems Yes Yes
11. Estimate construction cost Yes Yes Yes

Laboratory Building Design Questionnaire

No. __ Date __ Project Name __ Room No. __

A Identification

1 Building __

2 Room No. __

3 Department __

4 Division __

5 Affiliation __

B Room Description

6 Activities __

7 General type: Laboratory ____ Laboratory office ____ Administration ____

　Individual ____ Auxiliary laboratory ____

8 Room type __

9 Net area ____

10 Risk rating: Fire ____ Biohazard ____

　　Explosion ____ Radiation ____

　　Toxicity ____ Reactivity ____

C Functional Relationships

11 Laboratory adjacency ____

12 Floor adjacency ____

13 Building adjacency ____

D Safety Facilities

14 Fire extinguisher — Type ____

15 Fire blanket — Type ____

16 Eyewash — Type ____

17 Shower — Type ____

18 Spill containment — Type ____

19 Safety level — Type ____

20 Other — Type ____

E Laboratory Furniture

[Figure: Table 2-2, Laboratory furniture configuration table; columns are "Type, Material, Outlets, Voltage, Water, Gas, Vacuum"; rows are "21 Side bench, 22 Low bench, 23 Central bench, 24 Sink, 25 Reagent shelf, 26 Bench stool, 27 Office desk".]

F Mechanical Standards

28 Temperature — Summer ____ Winter ____

29 Humidity — Summer ____ Winter ____

30 Air change rate — Total __ Fresh air __

31 Air pressure — Maximum positive pressure __

　　Maximum negative pressure __

32 Filters — Supply air __ Standard __ Additional __

　　Exhaust air __ Standard __ Additional __

33 Exhaust — Fume hood __ cfm __ Model __

　　Biosafety cabinet __ cfm __ Model __

　　Local exhaust __ cfm __ Model __

　　Glove box __ Pressure __ Model __

34 Vibration — Isolation __ Standard __ Additional __

35 Noise control — Decibel limit __

G Power (High Voltage)

36 Normal power — Circuits Voltage Outlets Breakers

37 Emergency power — Circuits Voltage Outlets ____

38 Air conditioning — Circuits Voltage Outlets ____

39 Uninterruptible power supply — Circuits Voltage Outlets ____

40 Main switch __

H Data and Communications

41 Telephone — Number of units __ Type __

42 Data — Number of outlets __ Cabling __ Faceplates __

43 Intercom / public address __

44 Security alarm type — Cabling __ Display __

45 Alarms / sensors — High/low temperature __

　　Humidity __

　　Power on/off __

I Lighting

46 Illuminance __

47 Special-purpose lamps __

48 Switches — Half load __

　　Dimmable __

　　Darkroom __

49 Task lighting — Type __

J Fire Protection Items

50 Sprinklers __

51 Dry-ice (CO₂) fire suppression __

52 Smoke detectors __

53 Special alarms __

K Water Supply

54 Process water — Hot/cold __

55 Potable water — Hot/cold __

56 Central purified water supply — MΩ grade __

57 Point-of-use purified water supply — MΩ grade __

58 Cooling water — Gallons/min __ Temperature __

59 Laboratory sinks — Size __ Quantity __

60 Cup sinks — Quantity __

61 Floor drains __

62 Emergency systems — Eyewash __ Shower unit __

63 Compressed air __

64 Nitrogen __

65 Carbon dioxide __

66 Bottled gases __

IV. Case Study Process

Medical laboratory design should generally follow the requirements of the Ministry of Health's General Guidelines for Biosafety in Microbiological and Biomedical Laboratories.

  1. Designing a laboratory is an independent and concrete process, but two issues must be considered: principle and flexibility.

  2. Laboratory design shall strictly follow regulatory requirements. The architect is responsible for identifying the relevant regulatory requirements. Throughout the space planning process there should be a staff member with laboratory work experience and an architect.

  3. In the planning stage, managers, planners, and architects should consult repeatedly and prepare a plan that demonstrates the rationality of the space, listing the use of each space and the interrelationships between different spaces.

  4. The rational allocation of space shall be determined according to the equipment to be placed. At the same time, the size of the laboratory space shall be determined with a view to future development, so that newly acquired instruments and equipment can be accommodated over a longer period, ensuring that clinical work is completed efficiently and safely.

The general principle of space allocation is to make staff feel comfortable without creating waste, taking into comprehensive consideration the number of staff, analytical methods, and the size of instruments. The size of the work space shall allow the maximum number of staff to work at the same time. The effective space shall be divided according to "three flows and three zones": the "three zones" are the clean zone (offices, rest rooms, study rooms), the semi-contaminated zone (changing rooms), and the contaminated zone (work areas, washing areas, specimen storage areas). The "three flows" are: patient flow, medical staff flow, and waste flow. The flows of people and materials shall be rational so as to avoid cross-infection, and a laboratory access control system shall be established restricting entry to staff only. The work area shall include the area occupied by staff and the space for moving about. Work space and circulation space shall be translated into the area occupied on the floor.

In the implementation of laboratory design, under normal circumstances, the area to which the laboratory belongs has already been planned for a certain zone by the architectural designer during the overall planning and design of the hospital building. Most laboratory designers are faced with requirements for the laboratory's interior design; the designer's main task is the design of the laboratory's indoor environment.

Therefore, what is summarized here is mainly some principles and experience regarding the laboratory's interior design.

The most critical aspect of medical laboratory design is the design of the laboratory floor plan. To produce a floor plan with a rational distribution of functions and a clear separation of the "three flows and three zones," the designer must carry out a great deal of meticulous research and analysis.

The first step is thorough preliminary communication with the laboratory users to fully understand their specific requirements, such as the laboratory's departmental setup, the area requirements of each department, the location of the waste lift, and so on. On this basis, a detailed design brief is prepared. Sometimes the hospital prepares a design brief in advance and issues it to the designer during preliminary communication. In that case the designer should read the design brief carefully and, on the basis of fully understanding it and combined with the laboratory design area provided by the user, ensure that the laboratory design complies with the requirements of the design brief, so that a relatively ideal design solution can be produced.

The following is a design brief issued to the designer by the clinical laboratory department of a Grade III Class A hospital, as shown in Table 2-3.

Table 2-3 Medical Laboratory Design Brief

Function Name Quantity (rooms) Area (m²/room) Purpose and Requirements Remarks
Clinical Testing Center
Laboratory area Phlebotomy room 10 100
Waiting area 1 200
Open laboratory 1 500 Centralized management of large routine equipment Purified water, wastewater discharge, floor trench, air disinfection, power supply (UPS)

Continued table

Function Name Quantity (rooms) Area (m²/room) Purpose and Requirements Remarks
Laboratory area Centralized UPS power supply 20 Load bearing, power distribution
Cytology room 1 30 Cell morphology examination such as bone marrow examination, exfoliative cytology Includes internal sample storage
(Hematology laboratory) 1 100 Blood analysis, coagulation tests, etc.
Body fluid laboratory 1 100 Testing of various body fluids, etc.
Protein testing room 1 100 Protein electrophoresis, mass spectrometry platform
Microbiology laboratory 1 300 National special inspection project; 6–7 subzones Purification treatment
Special testing room 1 Reserve
HIV testing laboratory (immunology laboratory) 1 100 National special inspection project; interior divided into 3 zones, shared with manual immunology testing laboratory Purified water, wastewater discharge, air disinfection, installation of biosafety cabinets
Molecular biology laboratory 1 200 National special inspection project; PCR interior divided into 4 zones with one-way passage; molecular technology, gene sequencing laboratories (8 rooms) Purified water, wastewater discharge, additional UV lamps, installation of biosafety cabinets
Cytogenetics laboratory 1 100 Needed for prenatal diagnosis and reproductive medicine; requires licensing for prenatal diagnosis and reproductive medicine May be adjacent to the PCR laboratory to share some equipment; fume hood required
Special specimen storage 1 50 Storage of special patient samples and laboratory quality assessment samples At least 2 large-capacity low-temperature freezers
Water treatment room 1 20 For production of purified water; provides deionized purified water for the laboratory Output ≥ 600 L/h; waterproofing, overflow water treatment, load bearing
Cold storage 2 40 Reagent storage and sample storage Exhaust treatment for sample storage
Washing and disinfection room 2 40 Divided into washing area, drying area, autoclaving area 380 V power, near the waste lift
Waste area Specimen disposal room 1 10 Adjacent to sample cold storage; equipped with 2 autoclaves; near the waste lift 380 V power, near the waste lift
PA room 1 Interior divided into clean supplies area and contaminated supplies area
Auxiliary area Network management 1 10 Network management for the testing center
Storage room 2 30 Storage of ambient-temperature reagents and consumables; storage of instrument accessories
Staff duty room 2 20 For duty use; separate for men and women

Continued table

Function Name Quantity (rooms) Area (m²/room) Purpose and Requirements Remarks
Auxiliary area Workwear disinfection room 1 60 Used by staff; in the semi-restricted area
Staff toilets 2 20
Semi-contaminated zone Medical staff changing room 2 100
Living area Staff break room 1 20
Director's office 1 15 Office facilities
Multifunctional meeting room 1 100 For training
Total 2380

After the design solution is completed, it is submitted to the hospital's designated person in charge. After the user has reviewed the design solution in detail, there is a basis for further communication; the designer's thinking becomes clearer as this communication progresses, and during this period there may be a number of revision cycles until both parties reach an agreed result.

At this point the conceptual/schematic design stage can be considered complete. This confirmed plan is the basis for the subsequent design development work, including the preparation of the project budget estimate for the laboratory.

After the floor plan is confirmed and before the design development work begins, the designer must visit the site of the proposed laboratory building to carry out an on-site survey, and make detailed notes on points that are unclear in the drawings. At the same time, the user is required to provide relevant building drawings such as the building's water and electricity, structural construction drawings, and building sections and elevations.

After the user and the designer sign the design commission agreement, the designer can begin the design development of the project.

The specific work of design development is mainly the production of the complete set of construction drawings. The laboratory construction drawings shall include the following: existing building condition drawings, floor plan, wall demolition drawings, wall masonry drawings, color-steel panel wall drawings, color-steel panel detail drawings, door and window index drawings, laboratory door and window schedules, floor finish layout, ceiling layout, lighting fixture layout, lighting fixture dimension drawings, side bench dimension drawings, electrical design notes, equipment and material schedules, electrical system diagrams, ceiling electrical lighting layout, floor plan electrical outlet layout, floor plan UPS outlet layout, floor plan low-voltage (ELV) layout, water supply and drainage system diagrams, floor plan water supply and drainage layout, and drainage positioning drawings.