5.2.1 Principles of Plan Layout of the Clean Surgical Department

(1) It should meet the requirements of hygiene and medical processes (aseptic technique, flows of people and goods, and clear separation of clean and dirty).

(2) Pollution pathways should be controlled in all respects and throughout the whole process (including air purification of the surgical department, delivery and distribution of sterile items, storage, aseptic technique operations, and disinfection treatment of items after use).

(3) The principle of concise, rapid, and efficient flow lines (all work trajectories and links of personnel and goods flows should embody timeliness, thoughtfulness, and convenience).

(4) It should comply with the management requirements of the clean surgical department.

5.2.2 Basis for the Plan Layout of the Clean Surgical Department

(1) The plan layout of the clean surgical department is based on the composition of the surgical department, taking the operating room as the core and configuring the necessary auxiliary rooms to form a relatively independent medical functional unit (Figure 5.2).

(2) The determination of the scale of the clean surgical department (number of operating rooms) generally follows the empirical data of one operating room per 50 beds or per 25 surgical beds. Each operating room performs an average of 2–3 operations per day. The number can also be determined according to the actual demand statistics and long-term development requirements of the different medical specialties of each hospital. Therefore, the number of operating rooms is also closely related to the nature of the hospital.

(3) It can also be calculated by the following formula:

$$A = frac{B times 365}{T times W times N}$$

where: $A$——number of operating rooms;

$B$——total number of beds for patients requiring surgery; Figure 5.2 Composition and Functional Relationship of the Clean Operating Department

$T$—average length of hospital stay (days);

$W$—annual working days of the operating room (days);

$N$—average number of operations per operating room per day.

(4) To improve the surgical efficiency of the operating room and the close coordination between anesthesia and surgery, the operating department may set up anesthesia preparation rooms in a centralized or decentralized manner; the anesthesia preparation room is equipped with medical gas sources, writing desks, data information points, single-head suspended or vertical shadowless lamps, anesthesia instrument cabinets, anesthesia machines, etc.

(5) The setting of clean operating room standards generally depends on the type of surgery. Aseptic surgeries should preferably be performed in operating rooms of Class III or above, while aseptic surgeries involving vital organs, organ transplantation, and cosmetic procedures should be performed in Class I purification operating rooms. Generally, Class I operating rooms account for no more than 15% of the total number of operating rooms (limited to general hospitals, which both meets usage requirements and helps save investment).

(6) The determination of the area of a single clean operating room depends on the complexity of the various surgeries and the number of therapeutic instruments used.

(7) The combination forms of clean operating rooms can be divided into two types: with an anteroom and without an anteroom.

1) Clean operating room with an anteroom: generally composed of a scrub room, an anesthesia preparation room, a rinsing and disinfection room, and one operating room [see Figure 5.3(a,b)]. Table 5.1 Reference Plan Dimensions for Clean Operating Rooms

Type Minimum Net Area/m² Reference Dimensions (Length×Width)/m×m Reference Occupancy Capacity
Extra-large Operating Room 40~50 7.5×5.7 12 or more people
Large Operating Room 30~35 5.7×5.4 10 or more people
Medium Operating Room 25~30 5.4×4.8 8 or more people
Small Operating Room 20~25 4.8×4.2 6 or more people

(a) Arrangement that should be adopted

(b) Arrangement that should not be adopted

Figure 5.3 Clean Operating Room with Anteroom (the door between the scrub room and the operating room is a double-acting swing door; the same applies below)

The anesthesia preparation room is located at the entrance of each operating room for anesthesia preparation, which can improve the utilization rate of the operating room. The flushing and disinfection room is set at the exit of each operating room, used for disinfection and cleaning of the operating room as well as for handling of used items and waste.

Clean operating rooms with an anteroom adopt a single-corridor layout, whereas the operating room with anteroom arranged as shown in Figure 5.3(b) is redundant and wasteful, and should not be adopted.

2) Clean operating room without anteroom: It is composed of the operating room together with a scrub room and a cleaning and disinfection room arranged on its side or in front of it; the scrub room may also be arranged in the clean corridor, see Figure 5.4(a~c).

(8) Auxiliary rooms within the clean operating department.

1) Anesthesia preparation room (pre-anesthesia room): Patients receive pre-anesthesia here before undergoing surgery, which improves the utilization rate of clean operating rooms. The room is equipped with a single-head shadowless operating lamp, an operating table, medical gases, an anesthesia instrument cabinet, and a medicine cabinet.

2) Scrub room. It is used by the surgical medical staff for washing and disinfecting their hands, and should be located as close to the operating rooms as possible to avoid infection. Generally, one scrub room is provided for two to four operating rooms (or one may be provided for two rooms), and it may also be located in the clean corridor. Figure 5.4 Clean Operating Room without Anteroom

3) Flushing and disinfection room: As a room for on-site disinfection treatment, it is an indispensable auxiliary room of the clean operating room. It may correspond one-to-one with operating rooms, or two or more operating rooms may share one disinfection room. It is equipped with a flushing disinfector (electric heating or steam type, with water supply/drainage and exhaust facilities, using 85℃ hot water for closed disinfection of instruments, appliances, and tubing used in surgery), a washing sink, and sealed waste carts.

4) Aseptic storage room: Stores the sterile dressings and instruments required for surgery; it may be arranged in a centralized or decentralized, separate manner, with the number and size determined according to the scale of each surgical department. Sterile supplies and sterile instruments may be stored separately or together, but since the central supply room and the operating rooms themselves also hold a certain amount of stock, this room should not be too numerous or too large. The distribution and storage flow of sterile supplies is: supply room → surgical department aseptic room (bulk storage) → operating room. 5) Nurses' Station: Located at the entrance of the surgical department for managing personnel entering and exiting; it should be equipped with logistics transmission systems, data information points, and other facilities.

6) Disposable Supplies Storage: The clean surgical department should set up a centralized disposable supplies storage room, with an anteroom (approximately 6m²) for unpacking boxes, unwrapping packages, and removing dust before entering the disposable supplies storage room through the buffer room. Therefore, the anteroom is outside the clean area, the buffer room is between the two areas, and the storage room should have a door opening directly into the clean corridor for convenient access to disposable supplies.

7) Changing Room: Serves as the hygiene passage for staff, divided into the first changing room and the second changing room. The second changing room has cleanliness requirements; the first changing room is outside the clean area, and after changing shoes, undressing, and bathing/using the toilet, one enters the second changing room. Alternatively, a second shoe-changing point may be provided at the zone-crossing location to enter the second changing room. The area of the changing room is determined by factors such as the number of staff, the hygiene method, and locker occupancy (one locker per person or one locker per two persons, with the upper section for clothes and the lower section for shoes), generally 0.5~0.8m² per person.

8) Patient Transfer Room: Located at the entrance where patients enter the surgical department, set up across zones, where surgical patients are transferred between trolleys. The hygiene transfer process is: Patient → Enter the main entrance of the surgical department → External stretcher trolley docks with the surgical department's internal stretcher trolley for transfer → Enter the clean corridor of the surgical department → Enter the operating room → Transfer parallel to or docked with the operating table → End of surgery → ICU bed or stretcher trolley placed alongside the operating table → Patient transported to the ICU or ward.

9) Toilet: Generally located before undressing and showering; if layout is difficult, it must still be located before putting on scrub clothes, and should be equipped with a negative-pressure exhaust device. Figures 5.5 and 5.6 present two hygiene passage schemes.

Figure 5.5 General Hygiene Passage

10) Family Waiting Room: For family members of surgical patients to wait and rest, generally located outside the surgical department, which may be planned at 2~4 persons per operating room, with 1~1.5m² per person. A consultation room should be provided adjacent to the surgical department (one side facing the family waiting room, the other side connected to the clean corridor of the clean surgical department), facilitating communication with family members during surgery.

11) Other Rooms: Demonstration rooms (consultation rooms), offices, lounges, duty rooms, storage rooms, dressing washing rooms, etc., should all be located outside the clean area.

12) Hospitals with teaching tasks should install camera devices in operating rooms; operating room cameras are divided into two types: panoramic cameras and cameras on the shadowless lamp or headlamp aimed at the surgical field. Figure 5.6 Hygiene passages separated for pre-operative and post-operative use

5.2.3 Interior Layout Design of the Clean Operating Department

The interior layout design of the clean operating department takes the clean operating room as its core and combines it with the necessary auxiliary rooms, so as to achieve a rational medical process, clear zoning, and a distinct separation between clean and dirty flows, minimizing contact infection and preventing cross-infection.

(1) Zoning of the clean operating department.

The clean operating department should be strictly divided into a clean zone and a non-clean zone. The handling of rooms and passages in the clean zone and the non-clean zone should satisfy the medical process. The principle provisions of the Code are shown in Figure 5.7.

(2) Clean flow line design of the clean operating department.

The clean flow lines of the clean operating department must be clearly distinguished and the processes rational, so as to effectively prevent cross-infection, shorten operation routes, reduce the labor intensity of the staff, and improve surgical quality.

1) Personnel flow routes: Personnel passages should be simple and direct. The processes for patients and medical staff are as follows:

① Before patients enter the clean corridor of the operating department, hygiene procedures such as changing patient carts and changing gowns/bedding should be carried out (Figure 5.8).

② Doctors and nurses are the most active personnel in the operating department before and during operations; therefore, medical staff directly affect the cleanliness quality of the operating room, so strict hygiene treatment must be carried out (Figure 5.9).

2) Material flow routes: Sterile dressings, sterile instruments, and disposable items used in the clean operating room enter the operating room through the clean corridor. Items used in the operating room (dressings, instruments, waste) must be disinfected on-site or nearby by physical or chemical methods, packaged, and sent out of the operating room (via either the soiled corridor or the clean corridor), and then sent outside the operating department (Figure 5.10).

(3) Layout modes of the clean operating department.

There are many methods for the interior layout of the clean operating department, in various forms, each with its own advantages and disadvantages, but they should comply with hygienic requirements as well as zoning Figure 5.7 Zoning Principles

Figure 5.8 Patient Flow

Figure 5.9 Medical Staff Flow

Rational and with a clear separation of clean and dirty zones. Hospitals may select an appropriate location and determine the layout according to their specific circumstances. The following are several basic approaches.

1) Operating room with anterooms: It consists of three anterooms—the scrub room, the anesthesia preparation room, and the rinsing and disinfection room—together with an operating room zone; its flow is shown in Figure 5.11. Figure 5.10 Logistics flow

Figure 5.11 Personnel flow

Its advantages are: anesthesia preparation, flushing and disinfection, and scrubbing form a complete configuration with the operating room, offering high efficiency, strong assurance of aseptic technique operations, clear separation of clean and dirty zones, strict handling procedures, and better compliance with hygienic requirements, see Figure 5.12.

Figure 5.12 Layout of operating room with anteroom

2) Operating room without anteroom, single-corridor type: composed of the operating room together with its side flushing and disinfection room and scrub room, with anesthesia preparation arranged in a centralized manner; the flow is shown in Figure 5.13.

Its advantages are: high building utilization while meeting hygienic requirements, and savings from eliminating scattered anesthesia preparation rooms; the equipment configuration quantities for flushing, disinfection, etc. are shown in Figure 5.14. Figure 5.13 Single-corridor workflow without anteroom

Figure 5.14 Layout of single-corridor operating room without anteroom

Figure 5.15 Double-corridor workflow without anteroom

Figure 5.16 Double-corridor operating room without anteroom 3) Double-corridor operating room without anteroom: It consists of operating rooms together with a clean corridor and a semi-clean corridor. The washing/disinfection room and the scrub room may be arranged collectively or separately, while the anesthesia preparation room is arranged centrally. Its workflow is shown in Figure 5.15.

Its advantages are: a clear separation between clean and soiled flows, and relatively lower building utilization as well as washing/disinfection and anesthesia preparation volumes than those of the anteroom-type operating room, as shown in Figure 5.16.

4) Branched double-corridor (multi-corridor) layout without anteroom, suitable for large operating departments: its workflow is the same as that of the double-corridor type, as shown in Figure 5.17.

Figure 5.17 Branched double-corridor operating room without anteroom

5) Operating room with central island layout: its main purpose is to make it more convenient for sterile supplies to be delivered to the operating rooms via the sterile corridor, as shown in Figure 5.18.

5.2.4 Other Issues to Be Noted in the Plan Layout of the Clean Operating Department

(1) Elevators used within the clean operating department. If an elevator must be installed in the clean area, a buffer room should be provided at the elevator entrance and exit to isolate the contaminated airflow from interfering with the clean area.

(2) Air showers should not be installed in the clean operating department, because an air shower uses air at a certain velocity to blow dust off the surfaces of people and objects. Although it has a certain effect on ensuring cleanliness, patients cannot withstand being blown by high-velocity airflow; meanwhile, the raised floor of the air shower impedes the movement of surgical trolleys. If it were used by medical staff, since an ordinary operating department has several to dozens of operating rooms and the medical staff may number from dozens to over a hundred, multiple air showers would have to be used simultaneously to meet the usage requirements.

(3) The clean operating department should not straddle seismic joints, expansion joints, or settlement joints. This mainly ensures the airtightness during clean surgery, reduces contamination, is conducive to airflow organization, simplifies the design of building construction, and saves investment.

(4) The corridors in the clean operating department should generally be provided with smoke exhaust systems, automatic sprinkler systems, and fire alarm systems, while no sprinklers are installed inside the operating rooms. However, smoke detectors must not be omitted; plate-type smoke outlets should preferably be used for smoke exhaust, and the smoke detectors should be rust-proof and corrosion-resistant.

(5) The clean operating department should not straddle two fire compartments. If special circumstances require it to be located within two fire compartments, the setting of the fire compartments should not affect the normal use of the clean operating department.

(6) Medical oxygen in the clean operating department should preferably be supplied separately by the hospital oxygen station, and there should be a device capable of automatically cutting off the gas source in case of fire, or a manual shut-off device.

5.2.5 Shielding Materials

For X-ray protective operating rooms, 2mm lead plates should preferably be used as the radiation shielding material. Figure 5.18 Central Island Layout