"People-oriented" and "People and the environment" have become topics of great concern to people. Safety, efficiency, and comfort are the three major elements of an ideal experimental environment, and the purpose of laboratory construction.
Medical laboratories for biological, microbiological, immunological, chemical, hematological immunology, hematology, physiology, cytology, pathology, or other tests on materials taken from the human body should facilitate the correct implementation of testing and calibration, It should be ensured that its environmental conditions do not invalidate the results or adversely affect the required measurement quality. Therefore, the functional partition and plane layout of the laboratory, laboratory facilities and materials used, the disposal of laboratory waste and other related hardware conditions constitute a basic guarantee for whether the medical laboratory can achieve the construction purpose. In addition, the purpose and function of the laboratory for medical research and teaching should be constructed in accordance with the standards of the medical laboratory.
Medical laboratory testing is an important part of the vast majority of medical and health institutions, such as various types of hospitals, disease prevention and control centers, occupational disease prevention and treatment institutes, pharmaceutical factory enterprises, pharmaceutical research institutions, various testing institutions, and medical and health schools in colleges and universities jobs.
The construction of medical laboratories must abide by the relevant national laws and regulations, proceed from the reality of work, and correctly handle the relationship between the status quo and development, needs and possible. Must adhere to the principles of science, rationality, practicality and economy, according to factors such as workload, service content and demand, combined with regional economic development level and health planning, while meeting basic functions, reflecting the characteristics of standardization, intelligence and humanization To properly consider the needs of future development and determine the scale of laboratory construction.
1.1 The construction standards are closely related to the quality standards of medical laboratories. There are mainly two forms: legal documents represented by CLIA88 and recommended standards issued by ISO. In 1967, the US Congress passed a law specifically for the quality management of clinical laboratories, namely the Clinical Laboratory Improvement Act 1967 (CLIA'67). Twenty years after the implementation of this Act, an amendment to CLIA'67 was passed in 1988, that is, an amendment to the Clinical Laboratory Improvement Amendment '88 (CLIA '88), which was formally implemented in 1992.
The International Organization for Standardization issued IS017025: 1999 "General Requirements for the Capability of Testing and Calibration Laboratories" in 1999, applicable to all laboratories involved in testing and calibration, including medical laboratories. However, in addition to the same features as general industrial testing, medical laboratories have many specialities, because the objects it detects are various substances from the human body. IS017025 inevitably exists in the standardized use of medical laboratories. some problems. In 2001, the International Organization for Standardization formulated and passed the management standards for medical laboratories and officially released them in 2003, namely ISO 15189: 2003 "Special Requirements for the Quality and Capability of Medical Laboratories."
The China National Accreditation Board for Laboratories (CNAL) announced in May 2004 that laboratories can choose ISO / IEC17025 or IS015189 as the accreditation criteria for medical laboratories according to their own work characteristics and market needs. For accredited CNAL according to IS0 / IEC17025 Medical laboratories can decide to continue to maintain this accreditation or convert to IS015189 accredited laboratories according to their own needs. When converting, they need to revise their quality management system according to this standard to be able to meet the quality and ability of CNAL / AC23 "Medical Laboratories "Acceptance Criteria" (equivalent to IS015189) requirements, and began accepting applications for accreditation on July 1, 2004.
In order to meet the needs of Chinese medical laboratories in the medical and health and related fields, the China National Accreditation Board (CNAL-China National Accreditation Board For Laboraories) released the first edition of IS015189: 2003 (E) "Medical Laboratories" on 02.15, 2003. "Special Requirements for Quality and Capability", CNAL AC23-2003 "Guidelines for Accreditation of Medical Laboratories" was issued on September 11, 2003, which is equivalent to IS015189: 2003 (E).
In addition, from July 27 to 29, 2004, the drafting meeting of the national standard for "Safety Requirements for Medical Laboratories" was held in Beijing. The drafted "National Safety Requirements for Medical Laboratories" national standard is equivalent to adopting IS015190: 2003 international standard, and the work of establishing national standards for safety requirements for medical laboratories has been initially completed.
The industry standard for biosafety laboratories, "General Guidelines for Biosafety in Microbiology and Biomedical Laboratories" (WS233-2002), and national and industry standards for ventilation, exhaust, waste and solid waste treatment constitute medical laboratory design, construction, and management Legal basis.
1.2 Overview of overall planning and design The ISO15189 standard states that "laboratories should allocate space reasonably to ensure completion of work tasks without affecting work quality, quality control procedures, staff safety, and patient medical care services." Medical laboratories should be designed in accordance with the purpose of effective operation, and should make staff feel reasonable and comfortable, and at the same time minimize the risk of injury and occupational diseases. Patients, staff and visitors should be protected from certain known hazards. Biological hazards, fire protection, electrical appliance safety, chemical safety, radiation, hazardous waste disposal and disposal all require the use of scientific, efficient, and reliable technologies and means to ensure the optimization of laboratory systems.
In terms of functional division and division, medical laboratories in medical institutions are divided according to biology, microbiology, immunology, chemistry, blood immunology, hematology, physiology, cytology, and pathology; while medical research and teaching units Many are based on public basic medical laboratories (chemistry, biochemistry, physics, preventive medicine), functional laboratory (physiology, pharmacology, pathophysiology), morphology laboratory (pathology, embryogenesis, microbes, biology, parasites) ) And professional subject laboratories (stomatology, traditional Chinese medicine, diagnostic basis, general overview of surgery).
At present, there is no national standard to regulate and require laboratories in China. At present, domestic laboratory planning and design staff are all other relevant professionals. In the process of work, they gradually figured out a set of generally unified ideas and methods suitable for laboratory planning and design, which has become an unwritten rule in the industry.
There are many contents involved in the overall planning and design of the laboratory, such as equipment and instruments in the laboratory, storage, storage, laboratory furniture, personnel safety facilities, building fire protection requirements, product layout, water and electricity reserved positions, circuit wiring, water supply and drainage , Through exhaust system and laboratory three waste purification and environmental protection, etc.
The overall planning and design of the laboratory includes the following parts:
1. Planning and design of product plane layout: Provide professional advice to the user department to design product layout planning that meets laboratory standards and usage requirements. Determine the number of product types and specifications in the laboratory so that they can meet the laboratory requirements and standards.
2. Design of reserved locations for hydropower: After the layout is determined, our company will provide a comprehensive hydropower location map and hand it over to customers for construction.
3. Design of ventilating and exhausting system: In the new construction or renovation project of the laboratory, we participated in the planning, and sent professional engineers to the site to contact the relevant personnel, according to the number of ventilation carriers in the laboratory (such as fume hood Collecting hood exhaust hood) designed a complete ventilation program, the program content includes the location and size of the tube well reserved for exhaust in the building, the distribution and specifications of the pipeline. Ensure that the wind speed, exhaust, noise and other indicators of the ventilated carrier are in line with national standards, and are independent of the air-conditioning, fire-fighting and lighting lines in the building.
4. Environmentally friendly design: As the economy develops, people's requirements for environmental protection are becoming stricter. Our company provides a complete exhaust gas purification treatment solution, so that the exhaust gas generated in the experiment can be effectively resolved, in line with environmentally friendly emission targets.
5. Product personality design: According to the experiment process and the special requirements of personnel, adjust the product structure and function, design a personalized product to meet the user's requirements.
6. Design of safety facilities: In accordance with international standards, safety facilities such as safety cabinets, drug cabinets, emergency showers, and emergency eyewashes are installed in the laboratory.
In the following chapters, the focus will be on the laboratory construction of the Center for Disease Control and Prevention, introducing the relevant standards, overall planning, functional zoning, reasonable layout and graphic design of the laboratory, as well as laboratory furniture, laboratory ventilation and exhaust systems, Infrastructure and basic conditions such as air purification, safety protection, and environmental protection.
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