Design requirements and construction standards for medical laboratories

Medical laboratory refers to a laboratory engaged in medical testing, mainly including biological, microbiological, immunological, pathological, and other tests on samples from the human body. Currently, it is mainly divided into two categories: third-party medical laboratories and hospital laboratory departments. The main experimental items include biochemical testing of various body fluids, immunological testing, microbiological testing, blood testing, cytological testing, and pathological examination of various tissues or organs. The results of testing projects play a crucial role in clinical diagnosis and treatment, so to ensure the safe conduct of these experiments, laboratory construction should not be underestimated and is related to life safety.

Compliance is the primary consideration in the design of all medical laboratories. The relevant regulatory authorities have basic requirements for laboratories, such as fire protection, construction, electricity consumption, and sewage discharge, which need to be designed, implemented, and accepted in accordance with basic regulatory requirements. Many hospitals now have a requirement for ISO15189 accreditation, so medical laboratory design also needs to be based on the ISO15189 standard.

First,Medical Laboratory Design Requirements

When designing the overall layout of a medical laboratory, in addition to considering the current usage needs, future development space should also be considered, such as the size requirements for equipment updates. In addition, it is necessary to comply with laws and regulations to ensure biological and physical safety, and humanized design has become an important component of modern laboratory design.

Rationalized Space

Different devices have different requirements for space, and rational space allocation is determined based on the placed equipment. From a development perspective, the size of laboratory space should be considered whether it can accommodate newly added instruments and equipment for a long time, as well as efficiently and safely complete clinical work.

Space Allocation Principles

The principle of space allocation should comprehensively consider factors such as the number of staff and instrument size, with the aim of providing a comfortable working environment for staff without wasting space.

Working Space

The size of the workspace should assume that a larger number of staff are working at the same time. Effective space should be divided into three major areas:

Clean area: office, lounge, study room;

Buffer zone: storage area, supply area;

Pollution area: work area, washing area, specimen storage area.

Among them, the work area should include the area occupied by staff and the space for walking back and forth, and the work space and walking space should be converted into the size of the area occupied on the floor.

Biological Safety

The laboratory has special requirements for biosafety. This includes necessary biosafety facilities, such as non manual hand washing devices and emergency eye washing devices at the exit; Part of the work with high pollution risks should be carried out in a secondary biosafety cabinet, and cleaning and pollution areas should be set up in accordance with the requirements of the BSL-2 laboratory.

Physical Security

In some laboratories, electrical short circuits lead to laboratory fires, causing damage to equipment on the same line; Due to the rupture of the water supply pipeline, the laboratory was flooded; Deterioration of reagents due to high storage temperature due to power outage or refrigerator malfunction; The inspection work was interrupted due to difficulties in maintenance caused by mice biting the equipment wiring. From the current situation, these laboratories that have not effectively avoided safety hazards often cause huge losses to the laboratory due to some accidental events. Therefore, in addition to normal safety, comprehensive consideration should also be given to improving circuit capacity, fireproof materials, power outage protection devices, and adding anti rodent entry devices.

With the development of sensing technology and mobile communication in recent years, some early warning systems have also been integrated into laboratory design and construction. For example, multiple points of detection and alarm can be achieved in temperature, humidity, fire, and flood, automatic emergency response, and real-time transmission to relevant management personnel to prevent the occurrence of larger accidents.

Scalability

In recent years, the development of hospitals has been faster and more, with more and more patients seeking medical treatment, resulting in an increasing number of test samples. Due to the fact that the laboratory did not anticipate its future development at the beginning of its design, the implementation of existing equipment did not match the actual demand, so many hospitals had to adjust and organize some space for the laboratory to use. But in the later stages of this solution, it usually increases the distance between the existing space and the original laboratory, as well as the circulation distance of people, objects, and specimens, which further increases the workload. So when planning and designing the laboratory, we should consider the space reserved for the future addition of specialties, projects, equipment, personnel office spaces, and training venues with a scalable approach. We should also reserve power, water, and network ports for the potential increase in equipment and facilities in the future, and further consider the development plan of the laboratory in the coming years.

Normative References

The reference to the General Guidelines for Biosafety in Microbiology and Biomedical Laboratories issued by the Ministry of Health has become a guideline clause of this standard. For dated reference documents, all subsequent amendments (excluding corrected content) or revisions are not applicable to this guideline. However, parties who have reached agreements based on this guideline are encouraged to study whether new versions of these documents can be used. If the referenced document is undated, its new version applies to this guide.

Space Design Requirements

The important content of laboratory planning includes spatial planning. Reasonable and appropriate laboratory space is the foundation for laboratory staff to conduct good testing quality and their own safety. Insufficient laboratory space not only affects the quality of work for relevant personnel, but also poses a safety hazard in the laboratory.

User-Friendly Design

The humanized design of the laboratory can improve the comfort of staff, improve work efficiency, and reduce work intensity. A laboratory with a good visual experience is also conducive to creating a good working atmosphere and cultivating rigorous work habits among staff. For example, whether the height of the worktable needs to be adjusted according to height, how the distance between the night duty room and the emergency area is reasonable, and whether the placement area of all instruments matches the workflow have all become aspects worth further optimization in modern laboratory design. Not only that, the humanized design of the laboratory will also provide patients with a good medical environment and alleviate their emotions. For the laboratory, it is often necessary to consider practical issues such as the spacious and comfortable waiting space for patients, the convenience of sample sampling, and the collection of test results.

Personalized Considerations

The selection of laboratory equipment should first consider actual needs, and not blindly pursue advanced, automated, and high-throughput technology and equipment. At present, there are also some laboratories that have far more equipment capabilities to choose from, some functions are completely unusable, and some automation facilities cannot match their own processes and systems. At the same time, the selection of equipment cannot only consider price. The quality, brand, and extended service of the equipment are all very important for future use. The selection of laboratory reagents, quality control, and calibration consumables is also very important, and quality needs to be fully considered. If the number of waiting personnel is not fully estimated during laboratory design, it will lead to insufficient waiting space, insufficient blood drawing space, and crowded personnel. The site will be very chaotic and will have to spend a lot of manpower and material resources on re planning.

Second,Medical laboratory layout planning

Unlike general decoration, the design and decoration of laboratories are more professional, which is reflected in the usage needs and standards of customers in different regions and hospitals.

From the early stage of design, it is necessary to scientifically layout the laboratory based on its area, shape, and functional requirements. Clear distinctions should be made between the pedestrian, logistics, sewage, and specimen flow channels in the laboratory, so that the layout of the laboratory is regular and the space utilization rate is sufficient. At the same time, the design of the laboratory must comply with fire safety requirements. For the laboratory, and even the entire hospital, there may not be the opportunity to use fire equipment from its construction to final relocation, but it is essential. In case of emergency, it is the best guarantee for the safety of all people in the building.

In addition, there may be differences in the usage habits of laboratory staff and testing projects carried out by hospitals at different levels and regions, such as flow cytometry rooms, tuberculosis culture rooms, gene sequencing rooms, etc. Not all hospitals have such qualifications and needs. Of course, the design of the laboratory should be forward-looking, and there is a possibility for hospitals to carry out these projects in the future. Therefore, upgrade space needs to be reserved during the design.

Third,Quality control of medical laboratory construction

In terms of engineering construction, the construction of a laboratory includes architecture, decoration, and structure; Air conditioning, ventilation, and purification; Water supply and drainage and gas supply; Electrical; Fire protection; Inspection and acceptance.

In construction projects, relevant national standards should be followed. Laboratory laboratories in general hospitals belong to first level laboratories, and for some special laboratories, they should meet the construction standards of second level laboratories. For research laboratories, the construction standards should be higher. The selection of materials for laboratory decoration is very important, as materials with the same function may have different overall effects due to different technical standards.

For example, the requirements for laboratory walls, cold storage walls, and bathroom walls are different. It is obviously inappropriate to use brick walls of the same thickness. The walls of the laboratory should not be prone to dust accumulation and easy to clean. The internal and external corners should be rounded off without leaving any clean dead corners. For cold storage walls, they should be insulated and insulated to avoid condensation from adjacent walls. For microbiological laboratories and PCR laboratories, the construction standards should be higher, with negative pressure requirements for local rooms. At the same time, it is necessary to ensure that there is an independent air conditioning system, ventilation, and exhaust system to ensure that indoor and external laboratory air circulation does not intersect.

Fourth,Problems that are prone to occur in design

Due to its biological hazards and other reasons, medical laboratories have put forward more special requirements for the protection of laboratory personnel and the prevention of cross infection of samples. Without understanding these detailed requirements, blind construction invisibly poses significant risks to the personal safety of laboratory personnel and the accuracy of experimental results.